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Article ; Online: Analytical Concordance of PD-L1 Assays Utilizing Antibodies From FDA-Approved Diagnostics in Advanced Cancers: A Systematic Literature Review.

Prince, Emily A / Sanzari, Jenine K / Pandya, Dimple / Huron, David / Edwards, Robin

JCO precision oncology

2021 Volume 5, Page(s) 953–973

Abstract: Four programmed death ligand 1 (PD-L1) immunohistochemistry assays (28-8, 22C3, SP263, and SP142) have been approved for use by the US Food and Drug Administration (FDA). Analytical concordance between these assays has been evaluated in multiple studies. ...

Abstract	Four programmed death ligand 1 (PD-L1) immunohistochemistry assays (28-8, 22C3, SP263, and SP142) have been approved for use by the US Food and Drug Administration (FDA). Analytical concordance between these assays has been evaluated in multiple studies. This systematic review included studies that investigated the analytical concordance of immunohistochemistry assays utilizing two or more PD-L1 antibodies from FDA-approved diagnostics for evaluation of PD-L1 expression on tumor or immune cells across a range of tumor types and algorithms. Methods: Literature searches were conducted in MEDLINE (via PubMed) and EMBASE to identify studies published between January 1, 2010, and March 31, 2019, that evaluated analytical concordance between two or more assays based on antibodies from FDA-approved assays. Proceedings of key oncology and pathology congresses that took place between January 2016 and March 2019 were searched for abstracts of studies evaluating PD-L1 assay concordance. Results: A total of 42 studies across a range of tumor types met the selection criteria. Concordance between 28-8-, 22C3-, and SP263-based assays in lung cancer, urothelial carcinoma, and squamous cell carcinoma of the head and neck was high when used to assess PD-L1 expression on tumor cells (TCs). SP142-based assays had overall low concordance with other approved assays when used to assess PD-L1 expression on TCs. Analytical concordance for assessment of PD-L1 expression on immune cells was variable and generally lower than for PD-L1 expression on TCs. Conclusion: A large body of evidence supports the potential interchangeability of 28-8-, 22C3-, and SP263-based assays for the assessment of PD-L1 expression on TCs in lung cancer. Further studies are required in tumor types for which less evidence is available.
MeSH term(s)	Antibodies/analysis ; B7-H1 Antigen/immunology ; Humans ; Immunohistochemistry ; Neoplasm Staging ; Neoplasms/diagnosis ; Neoplasms/immunology ; United States ; United States Food and Drug Administration
Chemical Substances	Antibodies ; B7-H1 Antigen ; CD274 protein, human
Language	English
Publishing date	2021-06-08
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.20.00412
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The Predictive and Prognostic Nature of Programmed Death-Ligand 1 in Malignant Pleural Mesothelioma: A Systematic Literature Review.

Mansfield, Aaron S / Brown, Rebecca J / Sammon, Cormac / Daumont, Melinda J / McKenna, Mike / Sanzari, Jenine K / Forde, Patrick M

JTO clinical and research reports

2022 Volume 3, Issue 5, Page(s) 100315

Abstract: Introduction: Given the emergence of combination of programmed cell death protein-1 and CTLA4 pathway blockade as effective treatment options in malignant pleural mesothelioma (MPM), there is interest in the extent to which programmed death-ligand 1 (PD- ...

Abstract	Introduction: Given the emergence of combination of programmed cell death protein-1 and CTLA4 pathway blockade as effective treatment options in malignant pleural mesothelioma (MPM), there is interest in the extent to which programmed death-ligand 1 (PD-L1) expression may be prognostic of clinical outcomes and predictive of response to anti-programmed death (ligand) 1 (PD-[L]1) therapies. Methods: MEDLINE and EMBASE electronic databases were searched until November 4, 2020. English-language randomized trials and observational studies that reported clinical outcomes and PD-L1 expression in adult patients (>18 or >20 y) with MPM were included. Forest plots were used to descriptively summarize clinical outcome data across studies. Results: A total of 29 publications were identified providing data on the research question. Among the studies in which anti-PD-(L)1 therapies were not specified to have been used, 63% (10 of 16) found patients with tumors expressing PD-L1 (typically >1%) to have poorer survival than those with tumors expressing lower levels of PD-L1. Among the studies in which anti-PD-(L)1 therapies were used, 83% (five of six) did not reveal an association between survival and PD-L1 tumor expression. The single study directly comparing outcomes between those treated and untreated with anti-PD-(L)1 therapies across different PD-L1 cutoffs did not identify any differences between the groups. Conclusions: The quality and consistency of the existing evidence base are currently insufficient to draw conclusions regarding a prognostic or predictive role of PD-L1 in MPM. Furthermore, high-quality studies on this topic are required to support the use of PD-L1 as a biomarker in MPM.
Language	English
Publishing date	2022-03-22
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2022.100315
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Article ; Online: A Review of Radiation-Induced Coagulopathy and New Findings to Support Potential Prevention Strategies and Treatments.

Kennedy, Ann R / Maity, Amit / Sanzari, Jenine K

Radiation research

2016 Volume 186, Issue 2, Page(s) 121–140

Abstract: Results from our recent studies have led to the novel hypothesis that radiation-induced coagulopathy (RIC) and associated hemorrhage occurring as part of the acute radiation syndrome (ARS) is a major cause of death resulting from radiation exposure in ... ...

Abstract	Results from our recent studies have led to the novel hypothesis that radiation-induced coagulopathy (RIC) and associated hemorrhage occurring as part of the acute radiation syndrome (ARS) is a major cause of death resulting from radiation exposure in large mammals, including humans. This article contains information related to RIC, as well as potential strategies for the prevention and treatment of RIC. In addition, new findings are reported here on the occurrence of RIC biomarkers in humans exposed to radiation. To determine whether irradiated humans have RIC biomarkers, blood samples were obtained from radiotherapy patients who received treatment for different types of malignancies. Blood samples from allogeneic hematopoietic cell transplantation (allo-HCT) patients obtained before, during and after irradiation indicated that exposure led to prolonged clot formation times, increased levels of thrombin-antithrombin III (TAT) complex and increased circulating nucleosome/histone (cNH) levels, which suggest potential coagulopathies in the allo-HCT patients. Since these allo-HCT patients received chemotherapy prior to radiotherapy, it is possible that the chemical agents could have influenced the observed results. Frozen plasma samples from radiotherapy patients with prostate, lung and breast cancer were also obtained for analyses of cNH levels. The results indicated that some of these patients had very high cNH blood levels. Analysis of cNH levels in plasma samples from irradiated ferrets also indicated increased cNH levels compared to preirradiation baseline levels. The results from irradiated animals and some radiotherapy patients suggest the possibility that anti-histone antibodies, which block the toxic effects of elevated cNH levels in the blood, might be useful as therapeutic agents for adverse biological radiation-induced effects. The detection of increased levels of cNH in some radiotherapy patient blood samples demonstrates its potential as a biomarker for diagnosing and/or predicting the propensity for developing coagulopathies/hemorrhage, offering possible treatment options with personalized medicine therapies for cancer patients.
MeSH term(s)	Animals ; Biomarkers/blood ; Blood Coagulation Disorders/blood ; Blood Coagulation Disorders/pathology ; Blood Coagulation Disorders/prevention & control ; Blood Coagulation Disorders/therapy ; Ferrets ; Histones/blood ; Humans ; Nucleosomes/metabolism ; Nucleosomes/radiation effects ; Radiation Injuries/blood ; Radiation Injuries/pathology ; Radiation Injuries/prevention & control ; Radiation Injuries/therapy
Chemical Substances	Biomarkers ; Histones ; Nucleosomes
Language	English
Publishing date	2016-07-26
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	80322-4
ISSN	1938-5404 ; 0033-7587
ISSN (online)	1938-5404
ISSN	0033-7587
DOI	10.1667/RR14406.1
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Article ; Online: Distinct vascular genomic response of proton and gamma radiation-A pilot investigation.

Ricciotti, Emanuela / Sarantopoulou, Dimitra / Grant, Gregory R / Sanzari, Jenine K / Krigsfeld, Gabriel S / Kiliti, Amber J / Kennedy, Ann R / Grosser, Tilo

PloS one

2019 Volume 14, Issue 2, Page(s) e0207503

Abstract: The cardiovascular biology of proton radiotherapy is not well understood. We aimed to compare the genomic dose-response to proton and gamma radiation of the mouse aorta to assess whether their vascular effects may diverge. We performed comparative RNA ... ...

Abstract	The cardiovascular biology of proton radiotherapy is not well understood. We aimed to compare the genomic dose-response to proton and gamma radiation of the mouse aorta to assess whether their vascular effects may diverge. We performed comparative RNA sequencing of the aorta following (4 hrs) total-body proton and gamma irradiation (0.5-200 cGy whole body dose, 10 dose levels) of conscious mice. A trend analysis identified genes that showed a dose response. While fewer genes were dose-responsive to proton than gamma radiation (29 vs. 194 genes; q-value ≤ 0.1), the magnitude of the effect was greater. Highly responsive genes were enriched for radiation response pathways (DNA damage, apoptosis, cellular stress and inflammation; p-value ≤ 0.01). Gamma, but not proton radiation induced additionally genes in vasculature specific pathways. Genes responsive to both radiation types showed almost perfectly superimposable dose-response relationships. Despite the activation of canonical radiation response pathways by both radiation types, we detected marked differences in the genomic response of the murine aorta. Models of cardiovascular risk based on photon radiation may not accurately predict the risk associated with proton radiation.
MeSH term(s)	Animals ; Aorta/radiation effects ; Apoptosis/genetics ; Apoptosis/radiation effects ; DNA Damage/genetics ; DNA Damage/radiation effects ; Dose-Response Relationship, Radiation ; Gamma Rays ; Genome/genetics ; Genome/radiation effects ; Genomics/methods ; Inflammation/genetics ; Male ; Mice ; Mice, Inbred C57BL ; Pilot Projects ; Protons ; Radiation, Ionizing
Chemical Substances	Protons
Language	English
Publishing date	2019-02-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0207503
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The effects of proton radiation on the prothrombin and partial thromboplastin times of irradiated ferrets.

Krigsfeld, Gabriel S / Sanzari, Jenine K / Kennedy, Ann R

International journal of radiation biology

2012 Volume 88, Issue 4, Page(s) 327–334

Abstract: Purpose: To determine whether proton radiation affects coagulation.: Material and methods: Ferrets were exposed to solar particle event-like proton radiation at doses of 0, 25, 100, or 200 centigray (cGy), and dose rates of 50 cGy/minute (high dose ... ...

Abstract	Purpose: To determine whether proton radiation affects coagulation. Material and methods: Ferrets were exposed to solar particle event-like proton radiation at doses of 0, 25, 100, or 200 centigray (cGy), and dose rates of 50 cGy/minute (high dose rate or HDR) or 50 cGy/hour (low dose rate or LDR). Plasma was isolated from blood collected prior to radiation exposure and at 3-7 h post-radiation. Prothrombin time (PT) assays and activated partial thromboplastin time (aPTT) assays were performed as were mixing studies to determine the coagulation factors involved. Results: HDR and LDR exposure led to statistically significant increases in PT values. It was determined that the HDR-induced increase in PT was due to Factor VII, while Factors II, V, and VII contributed to the LDR-induced increase in PT values. Only acute LDR exposure caused an increase in aPTT values, which remained elevated for 48 h post-irradiation (which was the latest time assayed in these studies). Mixing studies revealed that Factor IX contributed to the increased aPTT values. A majority of the animals exposed at the LDR had an International Normalized Ratio approaching or surpassing 2.0. Conclusions: PT/aPTT assays resulted in increased clotting times due to different coagulation factors, indicating potential radiation-induced coagulopathy.
MeSH term(s)	Animals ; Blood Coagulation/radiation effects ; Dose-Response Relationship, Radiation ; Ferrets ; Partial Thromboplastin Time ; Prothrombin/metabolism ; Prothrombin Time ; Protons/adverse effects ; Restraint, Physical ; Solar Activity ; Thromboplastin/metabolism ; Time Factors
Chemical Substances	Protons ; Prothrombin (9001-26-7) ; Thromboplastin (9035-58-9)
Language	English
Publishing date	2012-02-06
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3065-x
ISSN	1362-3095 ; 0020-7616 ; 0955-3002
ISSN (online)	1362-3095
ISSN	0020-7616 ; 0955-3002
DOI	10.3109/09553002.2012.652727
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Article ; Online: Comparative analysis of colorimetric staining in skin using open-source software.

Billings, Paul C / Sanzari, Jenine K / Kennedy, Ann R / Cengel, Keith A / Seykora, John T

Experimental dermatology

2015 Volume 24, Issue 2, Page(s) 157–159

Abstract: Colorimetric staining techniques such as immunohistochemistry (IHC), immunofluorescence (IF) and histochemistry (HC) provide useful information regarding the localization and relative amount of a molecule/substance in skin. We have developed a novel, ... ...

Abstract	Colorimetric staining techniques such as immunohistochemistry (IHC), immunofluorescence (IF) and histochemistry (HC) provide useful information regarding the localization and relative amount of a molecule/substance in skin. We have developed a novel, straightforward method to assess colorimetric staining by combining features from two open-source software programs. As a proof of principle, we demonstrate the utility of this approach by analysing changes in skin melanin deposition during the radiation-induced tanning response of Yucatan mini-pigs. This method includes a visualization step to validate the accuracy of colour selection before quantitation to ensure accuracy. The data show that this method is robust and will provide a means to obtain accurate comparative analyses of staining in IHC/IF/HC samples.
MeSH term(s)	Animals ; Biopsy ; Colorimetry/methods ; Epidermis/metabolism ; Image Processing, Computer-Assisted ; Immunohistochemistry ; Melanins/chemistry ; Microscopy, Fluorescence ; Skin/metabolism ; Software ; Swine ; Swine, Miniature
Chemical Substances	Melanins
Language	English
Publishing date	2015-02
Publishing country	Denmark
Document type	Comparative Study ; Letter ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1130936-2
ISSN	1600-0625 ; 0906-6705
ISSN (online)	1600-0625
ISSN	0906-6705
DOI	10.1111/exd.12594
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Article ; Online: Comparison of changes over time in leukocyte counts in Yucatan minipigs irradiated with simulated solar particle event-like radiation.

Sanzari, Jenine K / Wan, X Steven / Muehlmatt, Amy / Lin, Liyong / Kennedy, Ann R

Life sciences in space research

2015 Volume 4, Page(s) 11–16

Abstract: During a major solar particle event (SPE), astronauts in space are at risk of exposure to an increased dose of proton radiation. The whole body distribution of the absorbed SPE proton dose is inhomogeneous, and such an inhomogeneous SPE proton dose can ... ...

Abstract	During a major solar particle event (SPE), astronauts in space are at risk of exposure to an increased dose of proton radiation. The whole body distribution of the absorbed SPE proton dose is inhomogeneous, and such an inhomogeneous SPE proton dose can be simulated by electron radiation. Using Yucatan minipigs as an animal model, we compared the time courses of leukocyte count changes after exposure to proton simulated SPE (pSPE) radiation or electron simulated SPE (eSPE) radiation. The results demonstrated that the time required after irradiation to reach the lowest leukocyte counts was generally comparable between the pSPE and eSPE radiation exposures. However, the leukocyte count often recovered faster after electron irradiation compared to proton irradiation at the corresponding doses. In addition, the radiation dose required to achieve comparable magnitudes of leukocyte count decrease was higher in the eSPE animals than for the pSPE animals. In conclusion, based on the magnitude of the decrease and the time required to reach the lowest leukocyte counts after irradiation, the pSPE radiation was more effective than the eSPE radiation in reducing the peripheral leukocyte counts. Lymphocytes appeared to be the most sensitive type of leukocytes in response to either type of SPE radiation. It is particularly noteworthy that following exposure to pSPE radiation at the skin doses >5 Gy, the neutrophils do not recover from the radiation damage at times up to 30 days, and the neutrophils have not recovered to their baseline levels even at 90 days post-irradiation. These results suggest a marked difference in the ability of the neutrophils to recover from pSPE radiation compared with the results observed for eSPE radiation.
MeSH term(s)	Animals ; Dose-Response Relationship, Radiation ; Electrons/adverse effects ; Extraterrestrial Environment ; Leukocyte Count ; Leukocytes/radiation effects ; Models, Animal ; Neutrophils/radiation effects ; Protons/adverse effects ; Radiation Dosage ; Radiation, Ionizing ; Solar Activity ; Swine ; Swine, Miniature
Chemical Substances	Protons
Language	English
Publishing date	2015-01
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ISSN	2214-5532
ISSN (online)	2214-5532
DOI	10.1016/j.lssr.2014.12.002
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Acute Hematological Effects in Mice Exposed to the Expected Doses, Dose-rates, and Energies of Solar Particle Event-like Proton Radiation.

Sanzari, Jenine K / Cengel, Keith A / Wan, X Steven / Rusek, Adam / Kennedy, Ann R

Life sciences in space research

2014 Volume 2, Page(s) 86–91

Abstract: NASA has funded several projects that have provided evidence for the radiation risk in space. One radiation concern arises from solar particle event (SPE) radiation, which is composed of energetic electrons, protons, alpha particles and heavier particles. ...

Abstract	NASA has funded several projects that have provided evidence for the radiation risk in space. One radiation concern arises from solar particle event (SPE) radiation, which is composed of energetic electrons, protons, alpha particles and heavier particles. SPEs are unpredictable and the accompanying SPE radiation can place astronauts at risk of blood cell death, contributing to a weakened immune system and increased susceptibility to infection. The doses, dose rates, and energies of the proton radiation expected to occur during a SPE have been simulated at the NASA Space Radiation Laboratory, Brookhaven National Laboratory, delivering total body doses to mice. Hematological values were evaluated at acute time points, up to 24 hrs. post-radiation exposure.
Language	English
Publishing date	2014-08-29
Publishing country	Netherlands
Document type	Journal Article
ISSN	2214-5532
ISSN (online)	2214-5532
DOI	10.1016/j.lssr.2014.01.003
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Article ; Online: Distinct vascular genomic response of proton and gamma radiation-A pilot investigation.

Emanuela Ricciotti / Dimitra Sarantopoulou / Gregory R Grant / Jenine K Sanzari / Gabriel S Krigsfeld / Amber J Kiliti / Ann R Kennedy / Tilo Grosser

PLoS ONE, Vol 14, Iss 2, p e

2019 Volume 0207503

Abstract	The cardiovascular biology of proton radiotherapy is not well understood. We aimed to compare the genomic dose-response to proton and gamma radiation of the mouse aorta to assess whether their vascular effects may diverge. We performed comparative RNA sequencing of the aorta following (4 hrs) total-body proton and gamma irradiation (0.5-200 cGy whole body dose, 10 dose levels) of conscious mice. A trend analysis identified genes that showed a dose response. While fewer genes were dose-responsive to proton than gamma radiation (29 vs. 194 genes; q-value ≤ 0.1), the magnitude of the effect was greater. Highly responsive genes were enriched for radiation response pathways (DNA damage, apoptosis, cellular stress and inflammation; p-value ≤ 0.01). Gamma, but not proton radiation induced additionally genes in vasculature specific pathways. Genes responsive to both radiation types showed almost perfectly superimposable dose-response relationships. Despite the activation of canonical radiation response pathways by both radiation types, we detected marked differences in the genomic response of the murine aorta. Models of cardiovascular risk based on photon radiation may not accurately predict the risk associated with proton radiation.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Induction of cytokine gene expression in human thyroid epithelial cells irradiated with HZE particles (iron ions).

Sanzari, Jenine K / Nuth, Manunya / Kennedy, Ann R

Radiation research

2009 Volume 172, Issue 4, Page(s) 437–443

Abstract: Gene expression profiles were examined using cDNA microarray technology in human thyroid epithelial (Htori-3) cells exposed to a low, non-toxic dose (10 cGy) of radiation from HZE particles in the form of iron ions in the absence or presence of ... ...

Abstract	Gene expression profiles were examined using cDNA microarray technology in human thyroid epithelial (Htori-3) cells exposed to a low, non-toxic dose (10 cGy) of radiation from HZE particles in the form of iron ions in the absence or presence of selenomethionine (SeM). A total of 215 genes were differentially regulated 2 h after exposure to a 10-cGy dose of iron-ion radiation. In the microarray analysis, SeM had profound effects on the radiation-induced expression of several specific genes, which includes PLAU, IGFBP3, FOLR1, B4GALT1 and COL1A1. Of particular interest to us was a gene cluster, "secreted proteins", that was up-regulated after radiation exposure. Seven up-regulated genes of this gene cluster fall within the chemokine/cytokine gene cluster, namely, CXCL1, CXCL2, IL6, IL11, IL8, IL24 and TGFbeta2. In microarray studies, the radiation-induced up-regulated expression of some these genes encoding cytokine/chemokine proteins was significantly decreased by SeM treatment. For IL8, TGFbeta2, CXCL1 and CXCL2, these observations were validated by qPCR techniques. It is concluded that SeM can regulate ionizing radiation-induced gene expression and may serve as an effective countermeasure for some of the acute inflammatory/immune responses induced by low-dose HZE-particle radiation.
MeSH term(s)	Astronauts ; Cell Line ; Cytokines/genetics ; Epithelial Cells/drug effects ; Epithelial Cells/metabolism ; Epithelial Cells/radiation effects ; Extraterrestrial Environment ; Gene Expression Profiling ; Humans ; Iron/pharmacology ; Oligonucleotide Array Sequence Analysis ; Radiation Dosage ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction ; Selenomethionine/pharmacology ; Thyroid Gland/cytology ; Transcriptional Activation/drug effects ; Transcriptional Activation/radiation effects
Chemical Substances	Cytokines ; Selenomethionine (964MRK2PEL) ; Iron (E1UOL152H7)
Language	English
Publishing date	2009-09-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	80322-4
ISSN	1938-5404 ; 0033-7587
ISSN (online)	1938-5404
ISSN	0033-7587
DOI	10.1667/RR1363.1
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