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Article ; Online: Cocreation in Health Workforce Planning to Shape the Future of the Health Care System in the Philippines.

Liwanag, Harvy Joy / Uy, Jhanna / Politico, Mary Ruth / Padilla, Mary Joy / Arzobal, Ma Catherine / Manuel, Kaycee / Cagouia, Angeli Loren / Tolentino, Pretchell / Frahsa, Annika / Ronquillo, Kenneth

Global health, science and practice

2022 Volume 10, Issue 6

Abstract: Background: The Philippines passed landmark legislation in 2019 on universal health coverage, including reforms in the development of its health workforce, an essential building block of responsive health care systems.: Health workforce planning ... ...

Abstract	Background: The Philippines passed landmark legislation in 2019 on universal health coverage, including reforms in the development of its health workforce, an essential building block of responsive health care systems. Health workforce planning cocreation process: We based our planning process on a model of cocreation defined as sharing power and decision making to solve problems collaboratively and build consensus around action. Through cocreation with policy makers, researchers, and other stakeholders, we performed projection studies on 10 selected health professions and estimated the need for primary care at national and subnational levels, which was the most extensive health workforce projection carried out by the Philippine Department of Health to date. We determined health workforce requirements based on target densities recommended by the World Health Organization and a health needs approach that considered epidemiological and sociodemographic factors. In consultation with stakeholders, we interpreted our analysis to guide recommendations to address issues related to health workforce quantity, skill mix, and distribution. These included a broad range of proposals, including task shifting, expanding scholarships and deployment, reforming health professionals' education, and pursuing a whole-of-society approach, which together informed the National Human Resources for Health Master Plan. Conclusions: Our cocreation model offers lessons for policy makers, program managers, and researchers in low- and middle-income countries who deal with health workforce challenges. Cocreation led to relationship building between policy makers and researchers who jointly performed the research and identified solutions through open communication and agile coordination. To shape future health care systems that are responsive both during normal times and during crises, cocreation would be essential for evidence-informed policy development and policy-relevant research.
MeSH term(s)	Humans ; Health Workforce ; Philippines ; Health Planning ; Delivery of Health Care ; Workforce
Language	English
Publishing date	2022-12-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2710875-2
ISSN	2169-575X ; 2169-575X
ISSN (online)	2169-575X
ISSN	2169-575X
DOI	10.9745/GHSP-D-22-00176
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Article ; Online: SGN-B7H4V, an investigational vedotin ADC directed to the immune checkpoint ligand B7-H4, shows promising activity in preclinical models.

Gray, Elizabeth / Ulrich, Michelle / Epp, Angela / Younan, Patrick / Sahetya, Disha / Hensley, Kelly / Allred, Sean / Huang, Li-Ya / Hahn, Julie / Gahnberg, Kristen / Treuting, Piper M / Trueblood, Esther S / Gosink, John J / Thurman, Robert / Wo, Serena / Spahr, Kellie / Haass, Evgenia Jane / Snead, Katie / Miller, Dannah /

Padilla, Mary / Smith, Alyson J / Frantz, Chris / Schrum, Jason P / Nazarenko, Natalya / Gardai, Shyra J

Journal for immunotherapy of cancer

2023 Volume 11, Issue 10

Abstract: Background: SGN-B7H4V is a novel investigational vedotin antibody-drug conjugate (ADC) comprising a B7-H4-directed human monoclonal antibody conjugated to the cytotoxic payload monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl ... ...

Abstract	Background: SGN-B7H4V is a novel investigational vedotin antibody-drug conjugate (ADC) comprising a B7-H4-directed human monoclonal antibody conjugated to the cytotoxic payload monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine citrulline (mc-vc) linker. This vedotin linker-payload system has been clinically validated in multiple Food and Drug Administration approved agents including brentuximab vedotin, enfortumab vedotin, and tisotumab vedotin. B7-H4 is an immune checkpoint ligand with elevated expression on a variety of solid tumors, including breast, ovarian, and endometrial tumors, and limited normal tissue expression. SGN-B7H4V is designed to induce direct cytotoxicity against target cells by binding to B7-H4 on the surface of target cells and releasing the cytotoxic payload MMAE upon internalization of the B7-H4/ADC complex. Methods: B7-H4 expression was characterized by immunohistochemistry across multiple solid tumor types. The ability of SGN-B7H4V to kill B7-H4-expressing tumor cells in vitro and in vivo in a variety of xenograft tumor models was also evaluated. Finally, the antitumor activity of SGN-B7H4V as monotherapy and in combination with an anti-programmed cell death-1 (PD-1) agent was evaluated using an immunocompetent murine B7-H4-expressing Renca tumor model. Results: Immunohistochemistry confirmed B7-H4 expression across multiple solid tumors, with the highest prevalence in breast, endometrial, and ovarian tumors. In vitro, SGN-B7H4V killed B7-H4-expressing tumor cells by MMAE-mediated direct cytotoxicity and antibody-mediated effector functions including antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. In vivo, SGN-B7H4V demonstrated strong antitumor activity in multiple xenograft models of breast and ovarian cancer, including xenograft tumors with heterogeneous B7-H4 expression, consistent with the ability of vedotin ADCs to elicit a bystander effect. In an immunocompetent murine B7-H4-expressing tumor model, SGN-B7H4V drove robust antitumor activity as a monotherapy that was enhanced when combined with an anti-PD-1 agent. Conclusion: The immune checkpoint ligand B7-H4 is a promising molecular target expressed by multiple solid tumors. SGN-B7H4V demonstrates robust antitumor activity in preclinical models through multiple potential mechanisms. Altogether, these preclinical data support the evaluation of SGN-B7H4V as a monotherapy in the ongoing phase 1 study of SGN-B7H4V in advanced solid tumors (NCT05194072) and potential future clinical combinations with immunotherapies.
MeSH term(s)	Animals ; Humans ; Mice ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Antineoplastic Agents/chemistry ; Cell Line, Tumor ; Disease Models, Animal ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Immunoconjugates/chemistry ; Immunohistochemistry ; Ligands
Chemical Substances	Antineoplastic Agents ; Immunoconjugates ; Ligands
Language	English
Publishing date	2023-10-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2719863-7
ISSN	2051-1426 ; 2051-1426
ISSN (online)	2051-1426
ISSN	2051-1426
DOI	10.1136/jitc-2023-007572
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Article ; Online: Simultaneous analysis of HER2 gene and protein on a single slide facilitates HER2 testing of breast and gastric carcinomas.

Hirschmann, Astrid / Lamb, Tiffany Ann / Marchal, Georges / Padilla, Mary / Diebold, Joachim

American journal of clinical pathology

2012 Volume 138, Issue 6, Page(s) 837–844

Abstract: This study sought to evaluate a new combined gene and protein detection platform in the context of HER2 evaluation in breast and gastric carcinomas. HER2 immunohistochemistry (IHC) and dual color in situ hybridization (Dual ISH) were combined on a single ...

Abstract	This study sought to evaluate a new combined gene and protein detection platform in the context of HER2 evaluation in breast and gastric carcinomas. HER2 immunohistochemistry (IHC) and dual color in situ hybridization (Dual ISH) were combined on a single slide. Results were compared with conventional HER2 IHC and fluorescence ISH. Results from the gene and protein assay were reliable and highly reproducible for both breast and gastric carcinomas. Concordance was found between conventional HER2 IHC and ISH testing and the gene and protein assay in the same laboratory (>95% for Dual ISH; lower for IHC because of different antibody clones), between IHC and Dual ISH performed on the same slide (>92%), and in the gene and protein assays between laboratories (>96%). This cost- and time-effective method provides fast and definitive results (IHC confirmed by means of Dual ISH) to aid in rapid treatment decisions. It can also be applied to other gene and protein combinations.
MeSH term(s)	Animals ; Antibodies, Monoclonal ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/genetics ; Biomarkers, Tumor/metabolism ; Breast Neoplasms/diagnosis ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Female ; Genes, erbB-2/genetics ; Genes, erbB-2/immunology ; Humans ; Immunohistochemistry ; In Situ Hybridization/methods ; In Situ Hybridization, Fluorescence/methods ; Mice ; Predictive Value of Tests ; Rabbits ; Receptor, ErbB-2/analysis ; Receptor, ErbB-2/genetics ; Receptor, ErbB-2/immunology ; Receptor, ErbB-2/metabolism ; Stomach Neoplasms/diagnosis ; Stomach Neoplasms/genetics ; Stomach Neoplasms/metabolism
Chemical Substances	Antibodies, Monoclonal ; Biomarkers, Tumor ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2012-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2944-0
ISSN	1943-7722 ; 0002-9173
ISSN (online)	1943-7722
ISSN	0002-9173
DOI	10.1309/AJCPL5IV0LAWSERG
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Article: Development of immunohistochemistry assays to assess GALNT14 and FUT3/6 in clinical trials of dulanermin and drozitumab.

Stern, Howard M / Padilla, Mary / Wagner, Klaus / Amler, Lukas / Ashkenazi, Avi

Clinical cancer research : an official journal of the American Association for Cancer Research

2010 Volume 16, Issue 5, Page(s) 1587–1596

Abstract: Purpose: In vitro sensitivity to the proapoptotic receptor agonists dulanermin (rhApo2L/TRAIL) and drozitumab (DR5-agonist antibody) is strongly predicted by the expression of the O-glycosylation enzymes GALNT14 in non-small cell lung cancer (NSCLC) ... ...

Abstract	Purpose: In vitro sensitivity to the proapoptotic receptor agonists dulanermin (rhApo2L/TRAIL) and drozitumab (DR5-agonist antibody) is strongly predicted by the expression of the O-glycosylation enzymes GALNT14 in non-small cell lung cancer (NSCLC) cell lines (among others) and of FUT3/6 in colorectal cancer (CRC) cell lines. We developed immunohistochemistry (IHC) assays that measure GALNT14 and FUT3/6 levels in archival formalin-fixed, paraffin-embedded human tumor tissue to determine marker prevalence in NSCLC and CRC tissue and to enable the future examination of these markers in clinical trials. Experimental design: GALNT14 or FUT3/6 ELISA-positive hybridoma clones were screened through IHC on cell pellets with known mRNA levels. The specificity of staining was examined in cell lines, normal tissue, and tumor tissue. Results: GALNT14 and FUT3/6 IHC exhibited a golgi staining pattern and correlated with GALNT14 and FUT3/6 (but not GALNT2 and FUT4) mRNA expression levels in cell lines and normal tissues, suggesting specificity. GALNT14 and FUT3/6 H-scores were significantly higher in cell lines sensitive to dulanermin (P = 0.01 and P = 0.0004, respectively) and drozitumab (P = 0.03 and P < 0.0001, respectively) versus resistant cell lines. GALNT14 and FUT3/6 H-scores varied widely, with approximately 45% of NSCLC samples exhibiting weak to moderate GALNT14 staining (H-score of at least 25) and 70% of CRC samples exhibiting moderate to strong FUT3/6 staining (H-score of at least 125). Conclusions: GALNT14 and FUT3/6 expression can be assessed in human tumors using sensitive and specific IHC assays. Both assays are being deployed in ongoing clinical trials of dulanermin and drozitumab to assess potential utility for patient selection.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/biosynthesis ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/metabolism ; Cell Line, Tumor ; Clinical Trials as Topic ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/metabolism ; Enzyme-Linked Immunosorbent Assay ; Fucosyltransferases/analysis ; Fucosyltransferases/biosynthesis ; Humans ; Immunohistochemistry/methods ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; N-Acetylgalactosaminyltransferases/analysis ; N-Acetylgalactosaminyltransferases/biosynthesis ; Sensitivity and Specificity ; TNF-Related Apoptosis-Inducing Ligand/therapeutic use
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents ; Biomarkers, Tumor ; TNF-Related Apoptosis-Inducing Ligand ; TNFSF10 protein, human ; Fucosyltransferases (EC 2.4.1.-) ; N-Acetylgalactosaminyltransferases (EC 2.4.1.-) ; 3-galactosyl-N-acetylglucosaminide 4-alpha-L-fucosyltransferase (EC 2.4.1.65) ; FUT6 protein, human (EC 2.4.1.65)
Language	English
Publishing date	2010-03-01
Publishing country	United States
Document type	Journal Article ; Validation Studies
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-09-3108
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Article ; Online: HER2 intratumoral heterogeneity analyses by concurrent HER2 gene and protein assessment for the prognosis of HER2 negative invasive breast cancer patients.

Kurozumi, Sasagu / Padilla, Mary / Kurosumi, Masafumi / Matsumoto, Hiroshi / Inoue, Kenichi / Horiguchi, Jun / Takeyoshi, Izumi / Oyama, Tetsunari / Ranger-Moore, Jim / Allred, D Craig / Dennis, Eslie / Nitta, Hiroaki

Breast cancer research and treatment

2016 Volume 158, Issue 1, Page(s) 99–111

Abstract: HER2 gene-protein assay (GPA) is a new method for the simultaneous evaluation of HER2 immunohistochemistry (IHC) and HER2 dual in situ hybridization (DISH) on single tissue sections of breast cancer. We investigated the presence of HER2 gene and protein ... ...

Abstract	HER2 gene-protein assay (GPA) is a new method for the simultaneous evaluation of HER2 immunohistochemistry (IHC) and HER2 dual in situ hybridization (DISH) on single tissue sections of breast cancer. We investigated the presence of HER2 gene and protein discrepancy and HER2-heterogeneity using HER2-GPA. HER2 status was analyzed for the correlation between the presence of HER2-heterogeneity and patient prognosis. Consecutive 280 invasive breast cancer were examined. Statuses of HER2 protein and gene were evaluated in whole tumor sections of HER2 GPA slides. HER2 protein and gene combination patterns were classified to six phenotypic and genotypic types for each case, as well as at individual cell levels: (A) IHC and DISH positive; (B) IHC positive and DISH negative; (C) IHC equivocal and DISH positive; (D) IHC equivocal and DISH negative; (E) IHC negative and DISH positive; and (F) IHC and DISH negative. The presence of HER2-heterogeneity was determined by the existence of at least two of six types within one tumor. HER2-IHC positive patients had significantly worse survival than IHC negative patients and HER2-DISH positive patients had significantly worse survival than DISH negative patients. HER2 IHC negative and DISH positive patients had significantly worse recurrence-free survival than IHC and DISH negative patients. In the HER2 IHC and DISH negative group, the HER2 heterogeneous group had significantly worse survival than the nonheterogeneous group. Notably, among triple negative breast cancer (TNBC), the HER2 heterogeneous group had significantly worse survival than the nonheterogeneous group. Our study suggests that the presence of HER2-heterogeneity might be a prognostic factor in HER2 negative breast cancer patients, especially in TNBC.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Female ; Genetic Heterogeneity ; Humans ; Middle Aged ; Prognosis ; Receptor, ErbB-2/genetics ; Receptor, ErbB-2/metabolism ; Survival Analysis
Chemical Substances	ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2016-06-18
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604563-7
ISSN	1573-7217 ; 0167-6806
ISSN (online)	1573-7217
ISSN	0167-6806
DOI	10.1007/s10549-016-3856-2
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Article ; Online: A gene-protein assay for human epidermal growth factor receptor 2 (HER2)

Nitta Hiroaki / Kelly Brian D / Padilla Mary / Wick Nikolaus / Brunhoeber Patrick / Bai Isaac / Singh Shalini / Ranger-Moore Jim / Bieniarz Chris / Tsuda Hitoshi / Grogan Thomas M

Diagnostic Pathology, Vol 7, Iss 1, p

brightfield tricolor visualization of HER2 protein, the HER2 gene, and chromosome 17 centromere (CEN17) in formalin-fixed, paraffin-embedded breast cancer tissue sections

2012 Volume 60

Abstract: Abstract Background The eligibility of breast cancer patients for human epidermal growth factor receptor 2 (HER2)-directed therapies is determined by the HER2 gene amplification and/or HER2 protein overexpression status of the breast tumor as determined ... ...

Abstract	Abstract Background The eligibility of breast cancer patients for human epidermal growth factor receptor 2 (HER2)-directed therapies is determined by the HER2 gene amplification and/or HER2 protein overexpression status of the breast tumor as determined by in situ hybridization (ISH) or immunohistochemistry (IHC), respectively. Our objective was to combine the US Food and Drug Administration (FDA)-approved HER2 & chromosome 17 centromere (CEN17) brightfield ISH (BISH) and HER2 IHC assays into a single automated HER2 gene-protein assay allowing simultaneous detection of all three targets in a single tissue section. Methods The HER2 gene-protein assay was optimized using formalin-fixed, paraffin-embedded (FFPE) samples of the xenograft tumors MCF7 [HER2 negative (non-amplified gene, protein negative)] and Calu-3 [HER2 positive (amplified gene, protein positive)]. HER2 IHC was performed using a rabbit monoclonal anti-HER2 antibody (clone 4B5) and a conventional 3,3'-diaminobenzidine IHC detection. The HER2 & CEN17 BISH signals were visualized using horseradish peroxidase-based silver and alkaline phosphatase-based red detection systems, respectively with a cocktail of 2,4-dinitrophenyl-labeled HER2 and digoxigenin-labeled CEN17 probes. The performance of the gene-protein assay on tissue microarray slides containing 189 randomly selected FFPE clinical breast cancer tissue cores was compared to that of the separate HER2 IHC and HER2 & CEN17 BISH assays. Results HER2 protein detection was optimal when the HER2 IHC protocol was used before (rather than after) the BISH protocol. The sequential use of HER2 IHC and HER2 & CEN17 BISH detection steps on FFPE xenograft tumor sections appropriately co-localized the HER2 protein, HER2 gene, and CEN17 signals after mitigating the silver background staining by using a naphthol phosphate-containing hybridization buffer for the hybridization step. The HER2 protein and HER2 gene status obtained using the multiplex HER2 gene-protein assay demonstrated high concordance with those obtained using the separate HER2 IHC and HER2 & CEN17 BISH assays, respectively. Conclusions We have developed a protocol that allows simultaneous visualization of the HER2 IHC and HER2 & CEN17 BISH targets. This automated protocol facilitated the determination of HER2 protein and HER2 gene status in randomly selected breast cancer samples, particularly in cases that were equivocal or exhibited tumor heterogeneity. The HER2 gene-protein assay produced results virtually equivalent to those of the single FDA-approved HER2 IHC and HER2 & CEN17 BISH assays. Virtual slides The virtual slides for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/2041964038705297
Keywords	Gene-protein assay ; Dual color in situ hybridization ; Immunohistochemistry ; HER2 ; Breast cancer ; Pathology ; RB1-214 ; Medicine ; R ; DOAJ:Pathology ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Subject code	616
Language	English
Publishing date	2012-05-01T00:00:00Z
Publisher	BioMed Central
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A gene-protein assay for human epidermal growth factor receptor 2 (HER2): brightfield tricolor visualization of HER2 protein, the HER2 gene, and chromosome 17 centromere (CEN17) in formalin-fixed, paraffin-embedded breast cancer tissue sections.

Nitta, Hiroaki / Kelly, Brian D / Padilla, Mary / Wick, Nikolaus / Brunhoeber, Patrick / Bai, Isaac / Singh, Shalini / Ranger-Moore, Jim / Bieniarz, Chris / Tsuda, Hitoshi / Grogan, Thomas M

Diagnostic pathology

2012 Volume 7, Page(s) 60

Abstract: Background: The eligibility of breast cancer patients for human epidermal growth factor receptor 2 (HER2)-directed therapies is determined by the HER2 gene amplification and/or HER2 protein overexpression status of the breast tumor as determined by in ... ...

Abstract	Background: The eligibility of breast cancer patients for human epidermal growth factor receptor 2 (HER2)-directed therapies is determined by the HER2 gene amplification and/or HER2 protein overexpression status of the breast tumor as determined by in situ hybridization (ISH) or immunohistochemistry (IHC), respectively. Our objective was to combine the US Food and Drug Administration (FDA)-approved HER2 & chromosome 17 centromere (CEN17) brightfield ISH (BISH) and HER2 IHC assays into a single automated HER2 gene-protein assay allowing simultaneous detection of all three targets in a single tissue section. Methods: The HER2 gene-protein assay was optimized using formalin-fixed, paraffin-embedded (FFPE) samples of the xenograft tumors MCF7 [HER2 negative (non-amplified gene, protein negative)] and Calu-3 [HER2 positive (amplified gene, protein positive)]. HER2 IHC was performed using a rabbit monoclonal anti-HER2 antibody (clone 4B5) and a conventional 3,3'-diaminobenzidine IHC detection. The HER2 & CEN17 BISH signals were visualized using horseradish peroxidase-based silver and alkaline phosphatase-based red detection systems, respectively with a cocktail of 2,4-dinitrophenyl-labeled HER2 and digoxigenin-labeled CEN17 probes. The performance of the gene-protein assay on tissue microarray slides containing 189 randomly selected FFPE clinical breast cancer tissue cores was compared to that of the separate HER2 IHC and HER2 & CEN17 BISH assays. Results: HER2 protein detection was optimal when the HER2 IHC protocol was used before (rather than after) the BISH protocol. The sequential use of HER2 IHC and HER2 & CEN17 BISH detection steps on FFPE xenograft tumor sections appropriately co-localized the HER2 protein, HER2 gene, and CEN17 signals after mitigating the silver background staining by using a naphthol phosphate-containing hybridization buffer for the hybridization step. The HER2 protein and HER2 gene status obtained using the multiplex HER2 gene-protein assay demonstrated high concordance with those obtained using the separate HER2 IHC and HER2 & CEN17 BISH assays, respectively. Conclusions: We have developed a protocol that allows simultaneous visualization of the HER2 IHC and HER2 & CEN17 BISH targets. This automated protocol facilitated the determination of HER2 protein and HER2 gene status in randomly selected breast cancer samples, particularly in cases that were equivocal or exhibited tumor heterogeneity. The HER2 gene-protein assay produced results virtually equivalent to those of the single FDA-approved HER2 IHC and HER2 & CEN17 BISH assays. Virtual slides: The virtual slides for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/2041964038705297.
MeSH term(s)	Automation, Laboratory ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/genetics ; Breast Neoplasms/chemistry ; Breast Neoplasms/genetics ; Centromere ; Chromosomes, Human, Pair 17 ; Female ; Fixatives ; Formaldehyde ; Gene Amplification ; Gene Expression Regulation, Neoplastic ; Humans ; Immunohistochemistry ; In Situ Hybridization ; MCF-7 Cells ; Observer Variation ; Paraffin Embedding ; Predictive Value of Tests ; Receptor, ErbB-2/analysis ; Receptor, ErbB-2/genetics ; Reproducibility of Results ; Tissue Array Analysis ; Tissue Fixation/methods
Chemical Substances	Biomarkers, Tumor ; Fixatives ; Formaldehyde (1HG84L3525) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2012-05-30
Publishing country	England
Document type	Evaluation Study ; Journal Article
ISSN	1746-1596
ISSN (online)	1746-1596
DOI	10.1186/1746-1596-7-60
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Article: Cardiac Wegener's granulomatosis masquerading as left atrial myxoma.

Herbst, Anne / Padilla, Mary T / Prasad, Anil R / Morales, Monty C / Copeland, Jack G

The Annals of thoracic surgery

2003 Volume 75, Issue 4, Page(s) 1321–1323

Abstract: A 56-year-old woman was referred with mitral regurgitation, left ventricular dysfunction, and a sessile mass on the anterior leaflet of her mitral valve. The initial impression from echocardiography was that she had a left atrial myxoma. At operation, we ...

Abstract	A 56-year-old woman was referred with mitral regurgitation, left ventricular dysfunction, and a sessile mass on the anterior leaflet of her mitral valve. The initial impression from echocardiography was that she had a left atrial myxoma. At operation, we found an intense inflammatory process diagnosed as Wegener's granulomatosis. It also involved the aortic valve and contiguous myocardium.
MeSH term(s)	Cardiomyopathies/diagnosis ; Diagnosis, Differential ; Female ; Granulomatosis with Polyangiitis/diagnosis ; Heart Atria ; Heart Neoplasms/diagnosis ; Humans ; Middle Aged ; Myxoma/diagnosis
Language	English
Publishing date	2003-04-07
Publishing country	Netherlands
Document type	Case Reports ; Journal Article
ZDB-ID	211007-6
ISSN	1552-6259 ; 0003-4975
ISSN (online)	1552-6259
ISSN	0003-4975
DOI	10.1016/s0003-4975(02)04662-3
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Article: A prospective study comparing oral sodium phosphate solution to a bowel cleansing preparation with nutrition food package in children.

El-Baba, Mohammad F / Padilla, Mary / Houston, Carmela / Madani, Shailender / Lin, Chuan-Hao / Thomas, Ronald / Tolia, Vasundhara

Journal of pediatric gastroenterology and nutrition

2006 Volume 42, Issue 2, Page(s) 174–177

Abstract: Objective: The inability of children to comply with bowel preparation regimens can result in inadequate visualization of the colon. This study compares the safety, efficacy, and patient acceptance of a prepackaged diet kit plus a magnesium citrate/ ... ...

Abstract	Objective: The inability of children to comply with bowel preparation regimens can result in inadequate visualization of the colon. This study compares the safety, efficacy, and patient acceptance of a prepackaged diet kit plus a magnesium citrate/bisacodyl bowel cleansing regimen with a clear liquid diet and sodium phosphate solution regimen in children undergoing colonoscopy. Methods: Children scheduled for a diagnostic colonoscopy, were randomly assigned to receive a prepackaged diet kit and a magnesium citrate/bisacodyl laxative (group 1), or clear liquids and sodium phosphate solution (group 2). The patients and their parents completed a questionnaire to evaluate acceptance of their assigned regimen before colonoscopy. The endoscopists, blinded to the type of bowel preparation, rated bowel cleansing. Results: Sixty two children (28 males, 34 females) with mean age 12.5 years participated. Thirty six and 26 patients were in groups 1 and 2 respectively. Overall cleansing was rated significantly superior in group 1 compared to group 2 as was amount of retained feces (P = .013 for both). The overall frequency of reported side-effects was lower in group 1 than (83.3%, 30/36) than in group 2 (100.0%, 26/26) (P = 0.03). The preparations were otherwise equivalent in regards to compliance and patient tolerance. Conclusions: Although both regimens were comparable in adequacy of colon visualization, preparation tolerance, side effects and compliance profile in this pilot study, the prepackaged diet kit with magnesium citrate/bisacodyl laxative resulted in superior colon cleansing.
MeSH term(s)	Adolescent ; Bisacodyl/pharmacology ; Cathartics/pharmacology ; Child ; Child, Preschool ; Citric Acid/pharmacology ; Colonoscopy ; Diet ; Double-Blind Method ; Female ; Humans ; Male ; Organometallic Compounds/pharmacology ; Patient Acceptance of Health Care ; Patient Compliance ; Phosphates/adverse effects ; Phosphates/pharmacology ; Pilot Projects ; Prospective Studies ; Safety ; Taste ; Treatment Outcome
Chemical Substances	Cathartics ; Organometallic Compounds ; Phosphates ; Bisacodyl (10X0709Y6I) ; Citric Acid (2968PHW8QP) ; magnesium citrate (RHO26O1T9V) ; sodium phosphate (SE337SVY37)
Language	English
Publishing date	2006-02
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial
ZDB-ID	603201-1
ISSN	1536-4801 ; 0277-2116
ISSN (online)	1536-4801
ISSN	0277-2116
DOI	10.1097/01.mpg.0000189353.40419.31
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Article ; Online: The impact of pre-analytical processing on staining quality for H&E, dual hapten, dual color in situ hybridization and fluorescent in situ hybridization assays.

Babic, Andrea / Loftin, Isabell R / Stanislaw, Stacey / Wang, Maria / Miller, Rachel / Warren, Stephanie M / Zhang, Wenjun / Lau, Alexandria / Miller, Melanie / Wu, Ping / Padilla, Mary / Grogan, Thomas M / Pestic-Dragovich, Lidija / McElhinny, Abigail S

Methods (San Diego, Calif.)

2010 Volume 52, Issue 4, Page(s) 287–300

Abstract: With the advent of personalized medicine, anatomic pathology-based molecular assays, including in situ hybridization (ISH) and mRNA detection tests, are performed routinely in many laboratories and have increased in their clinical importance and ... ...

Abstract	With the advent of personalized medicine, anatomic pathology-based molecular assays, including in situ hybridization (ISH) and mRNA detection tests, are performed routinely in many laboratories and have increased in their clinical importance and complexity. These assays require appropriately fixed tissue samples that preserve both nucleic acid targets and histomorphology to ensure reliable test results for determining patient treatment options. However, all aspects of tissue processing, including time until tissue fixation, type of fixative, duration of fixation, post-fixation treatments, and sectioning of the sample, impact the staining results. ASCO/CAP has issued pre-analytical guidelines to standardize tissue processing for HER2 testing in breast carcinoma specimens: 10% neutral-buffered formalin (NBF) with a fixation time from at least 6 to 48h [1]. Often, this recommendation is not followed to the detriment of staining results [2]. In this paper, we used a human breast carcinoma cell line (MCF7) generated as xenograft tumors as a model system to analyze the effects of different pre-analytical conditions on ISH staining. We performed H&E, FISH and dual colorimetric HER2 ISH assays using specimens fixed across a range of times in six different commonly used fixatives. Additionally, we investigated the effects of varying tissue section thickness, which also impacted the quality of ISH staining. Finally, we evaluated the effects of three different decalcifying solutions on human breast specimens, typically a treatment that occurs post-fixation for evaluating metastases to bone. The results indicate that time and type of fixation treatment, as well as appropriate tissue thickness and post-fixation treatment, all contribute to the quality of ISH staining results. Our data support the ASCO/CAP recommendations for standardized tissue processing (at least 6h in formalin-based fixatives and 4μm section thickness) and indicate that certain fixatives and post-fixative treatments are detrimental to molecular staining results.
MeSH term(s)	Animals ; Breast Neoplasms/chemistry ; Cell Line, Tumor ; Eosine Yellowish-(YS) ; Female ; Fixatives ; Haptens ; Hematoxylin ; Humans ; In Situ Hybridization/methods ; In Situ Hybridization, Fluorescence/methods ; Mice ; Receptor, ErbB-2/analysis ; Staining and Labeling ; Tissue Fixation/methods ; Transplantation, Heterologous
Chemical Substances	Fixatives ; Haptens ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Eosine Yellowish-(YS) (TDQ283MPCW) ; Hematoxylin (YKM8PY2Z55)
Language	English
Publishing date	2010-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	1066584-5
ISSN	1095-9130 ; 1046-2023
ISSN (online)	1095-9130
ISSN	1046-2023
DOI	10.1016/j.ymeth.2010.08.012
Database	MEDical Literature Analysis and Retrieval System OnLINE

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