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Article ; Online: Patterns of Enrollment in Cancer Treatment Trials During the COVID-19 Pandemic at National Cancer Institute-Designated Cancer Centers.

Prindiville, Sheila A / Sarosy, Gisele A / Loose, David / Ciolino, Henry / Doroshow, James H

2022 Volume 28, Issue 2, Page(s) 111–117

Abstract: Abstract: The COVID-19 pandemic posed unprecedented strain on enrollment to cancer clinical trials and their conduct. Here, we highlight an analysis using information from the National Cancer Institute (NCI) Clinical Trials Reporting Program database to ...

Abstract	Abstract: The COVID-19 pandemic posed unprecedented strain on enrollment to cancer clinical trials and their conduct. Here, we highlight an analysis using information from the National Cancer Institute (NCI) Clinical Trials Reporting Program database to describe enrollment patterns to interventional cancer treatment trials at NCI-Designated Cancer Centers during the pandemic. Enrollment to cancer treatment trials at NCI-Designated Cancer Centers decreased precipitously early in the pandemic and has not yet fully returned to the 2019 baseline as of mid-2021. We discuss possible reasons for this and how some of the changes in clinical trial conduct implemented during the pandemic may become part of the standard conduct of NCI-supported clinical trials and broaden access to trials.
MeSH term(s)	COVID-19/epidemiology ; Clinical Trials as Topic ; Databases, Factual ; Humans ; National Cancer Institute (U.S.) ; Neoplasms/epidemiology ; Neoplasms/therapy ; Pandemics ; Patient Participation/statistics & numerical data ; United States/epidemiology
Language	English
Publishing date	2022-03-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2018400-1
ISSN	1540-336X ; 1528-9117 ; 1081-4442
ISSN (online)	1540-336X
ISSN	1528-9117 ; 1081-4442
DOI	10.1097/PPO.0000000000000578
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Article ; Online: A call to action to advance patient-focused and decentralized clinical trials.

Cancer

2024 Volume 130, Issue 8, Page(s) 1193–1203

MeSH term(s)	Humans ; Delivery of Health Care
Language	English
Publishing date	2024-01-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.35145
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Article ; Online: Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Williams, Rebecca J / Dobbins, Heather D / Tse, Tony / Chon, Sandy D / Loose, David / Sarosy, Gisele A / Prindiville, Sheila A / Rockhold, Frank W / Zarin, Deborah A

BMJ (Clinical research ed.)

2022 Volume 377, Page(s) e067745

Abstract: Objective: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.!# ...

Abstract	Objective: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. Design: Qualitative analysis. Data sources: ClinicalTrials.gov trial registry. Main outcome measures: Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified. Results: A reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted). Conclusions: How the proposed approach allows for clear, descriptive, structured information about each substudy's prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally.
MeSH term(s)	Clinical Trials as Topic ; Databases, Factual ; Humans ; Qualitative Research ; Registries ; Research Design
Language	English
Publishing date	2022-06-10
Publishing country	England
Document type	Journal Article
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj-2021-067745
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Article ; Online: Characteristics of Breast Ducts in Normal-Risk and High-risk Women and Their Relationship to Ductal Cytologic Atypia.

Danforth, David N / Filie, Armando C / Warner, Andrew C / Wright, George W / Sun, Zhonghe / Ried, Thomas / McGowan, Christine T / Prindiville, Sheila A

Cancer prevention research (Philadelphia, Pa.)

2020 Volume 13, Issue 12, Page(s) 1027–1036

Abstract: Breast ductal cytologic atypia is an important risk factor for sporadic breast cancer. Characterization of the associated normal breast tissue is needed to develop additional methods of risk assessment and new targets for breast cancer prevention. We ... ...

Abstract	Breast ductal cytologic atypia is an important risk factor for sporadic breast cancer. Characterization of the associated normal breast tissue is needed to develop additional methods of risk assessment and new targets for breast cancer prevention. We conducted a prospective clinical trial evaluating women at normal-risk or at high-risk for sporadic breast cancer. Breast ductal cells were collected and studied cytologically and by gene expression profiling, and breast ductal architectural changes were studied by breast ductal endoscopy (BDE) and breast MRI. One hundred and forty subjects were studied, 70 at high risk (RR, 2.0-4.6) and 70 at normal risk. Cytologic atypia was present in 22.9% of high-risk and 25.7% of normal-risk subjects. Ductal endoscopy was performed in 89 subjects and revealed benign intraductal abnormalities, primarily intraductal fibrous webbing suggesting chronic inflammation, in 40.4% of high-risk and 5.4% of normal-risk subjects, respectively (
MeSH term(s)	Adult ; Aged ; Biomarkers, Tumor/genetics ; Biomarkers, Tumor/metabolism ; Breast/metabolism ; Breast/pathology ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Carcinoma, Ductal, Breast/genetics ; Carcinoma, Ductal, Breast/metabolism ; Carcinoma, Ductal, Breast/pathology ; Carcinoma, Intraductal, Noninfiltrating/genetics ; Carcinoma, Intraductal, Noninfiltrating/metabolism ; Carcinoma, Intraductal, Noninfiltrating/pathology ; Cytodiagnosis/methods ; Female ; Follow-Up Studies ; Gene Expression Profiling ; Gene Expression Regulation, Neoplastic ; Humans ; Middle Aged ; Prognosis ; Prospective Studies ; Risk Assessment/methods
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2020-08-04
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural
ZDB-ID	2434717-6
ISSN	1940-6215 ; 1940-6207
ISSN (online)	1940-6215
ISSN	1940-6207
DOI	10.1158/1940-6207.CAPR-19-0305
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Article ; Online: Interphase cytogenetics of sputum cells for the early detection of lung carcinogenesis.

Prindiville, Sheila A / Ried, Thomas

Cancer prevention research (Philadelphia, Pa.)

2010 Volume 3, Issue 4, Page(s) 416–419

Abstract: This perspective on Varella-Garcia et al. (beginning on p. 447 in this issue of the journal) examines the role of interphase fluorescence in situ hybridization for the early detection of lung cancer. This work is an important step toward identifying and ... ...

Abstract	This perspective on Varella-Garcia et al. (beginning on p. 447 in this issue of the journal) examines the role of interphase fluorescence in situ hybridization for the early detection of lung cancer. This work is an important step toward identifying and validating a molecular marker in sputum samples for lung cancer early detection and highlights the value of establishing cohort studies with biorepositories of samples collected from participants followed over time for disease development.
MeSH term(s)	Biomarkers, Tumor/analysis ; Biomarkers, Tumor/genetics ; Cytogenetics/methods ; Early Detection of Cancer/methods ; Humans ; In Situ Hybridization, Fluorescence ; Interphase ; Lung Neoplasms/diagnosis ; Lung Neoplasms/genetics ; Sputum/cytology
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2010-03-23
Publishing country	United States
Document type	Comment ; Journal Article ; Review
ZDB-ID	2434717-6
ISSN	1940-6215 ; 1940-6207
ISSN (online)	1940-6215
ISSN	1940-6207
DOI	10.1158/1940-6207.CAPR-10-0045
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Article ; Online: The National Cancer Institute and Department of Veterans Affairs Interagency Group to Accelerate Trials Enrollment (NAVIGATE): A federal collaboration to improve cancer care.

Schiller, Sara J / Shannon, Colleen / Brophy, Mary T / Denicoff, Andrea M / Good, Marjorie J / Prindiville, Sheila A / Huang, Grant D

Seminars in oncology

2019 Volume 46, Issue 4-5, Page(s) 308–313

Abstract: Cancer clinical trials represent an important option for patients with a diagnosis of cancer and the clinician-investigators involved in their care who seek options for their disease. For all who are impacted by cancer, these studies offer opportunities ... ...

Abstract	Cancer clinical trials represent an important option for patients with a diagnosis of cancer and the clinician-investigators involved in their care who seek options for their disease. For all who are impacted by cancer, these studies offer opportunities for greater learning. Conducting these important studies involves several challenges, including recruiting eligible participants. To address barriers that arise over the course of these activities, the Department of Veterans Affairs (VA) and National Cancer Institute (NCI) have partnered to increase Veteran participation in oncology clinical trials. This initiative, the NCI And VA Interagency Group to Accelerate Trials Enrollment, or NAVIGATE, is focused on addressing recruitment across the VA healthcare system and finding systematic solutions related to activating, recruiting for and conducting oncology clinical trials at VA Medical Centers. Additional goals include (1) establishing a sustainable network that can serve as a model for other VA sites interested in doing cancer clinical trials, (2) recruitment of minority patients, and (3) developing best practices and policies that can be deployed across the VA healthcare system. In this manuscript, we describe the scope, organization, activities, and future directions of NAVIGATE while also highlighting key needs for successfully conducting cancer clinical trials within the VA system. This partnership between 2 large federal agencies with a shared commitment to improving cancer care may provide lessons to others who are also dedicated to helping those affected by the disease.
MeSH term(s)	Clinical Trials as Topic/organization & administration ; Humans ; Medical Oncology/methods ; Medical Oncology/organization & administration ; Medical Oncology/standards ; National Cancer Institute (U.S.) ; Patient Care ; Patient Care Management/organization & administration ; Quality Improvement ; United States ; United States Department of Veterans Affairs
Language	English
Publishing date	2019-10-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	189220-4
ISSN	1532-8708 ; 0093-7754
ISSN (online)	1532-8708
ISSN	0093-7754
DOI	10.1053/j.seminoncol.2019.09.005
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Article: An Improved Breast Epithelial Sampling Method for Molecular Profiling and Biomarker Analysis in Women at Risk for Breast Cancer.

Danforth, David N / Warner, Andrew C / Wangsa, Darawalee / Ried, Thomas / Duelli, Dominik / Filie, Armando C / Prindiville, Sheila A

Breast cancer : basic and clinical research

2015 Volume 9, Page(s) 31–40

Abstract: Background: There is a strong need to define the molecular changes in normal at-risk breast epithelium to identify biomarkers and new targets for breast cancer prevention and to develop a molecular signature for risk assessment. Improved methods of ... ...

Abstract	Background: There is a strong need to define the molecular changes in normal at-risk breast epithelium to identify biomarkers and new targets for breast cancer prevention and to develop a molecular signature for risk assessment. Improved methods of breast epithelial sampling are needed to promote whole-genome molecular profiling, increase ductal epithelial cell yield, and reduce sample cell heterogeneity. Methods: We developed an improved method of breast ductal sampling with ductal lavage through a 22-gauge catheter and collection of ductal samples with a microaspirator. Women at normal risk or increased risk for breast cancer were studied. Ductal epithelial samples were analyzed for cytopathologic changes, cellular yield, epithelial cell purity, quality and quantity of DNA and RNA, and use in multiple downstream molecular applications. Results: We studied 50 subjects, including 40 subjects at normal risk for breast cancer and 37 subjects with non-nipple aspirate fluid-yielding ducts. This method provided multiple 1.0 mL samples of high ductal epithelial cell content (median ≥8 samples per subject of ≥5,000 cells per sample) with 80%-100% epithelial cell purity. Extraction of a single intact ductal sample (fluid and cells) or the separate frozen cellular component provided DNA and RNA for multiple downstream studies, including quantitative reverse transcription- polymerase chain reaction (PCR) for microRNA, quantitative PCR for the human telomerase reverse transcriptase gene, whole-genome DNA amplification, and array comparative genomic hybridization analysis. Conclusion: An improved breast epithelial sampling method has been developed, which should significantly expand the acquisition and biomarker analysis of breast ductal epithelium in women at risk for breast cancer.
Language	English
Publishing date	2015-06-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	2423804-1
ISSN	1178-2234
ISSN	1178-2234
DOI	10.4137/BCBCR.S23577
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Article ; Online: Relationships between computer-extracted mammographic texture pattern features and BRCA1/2 mutation status: a cross-sectional study.

Gierach, Gretchen L / Li, Hui / Loud, Jennifer T / Greene, Mark H / Chow, Catherine K / Lan, Li / Prindiville, Sheila A / Eng-Wong, Jennifer / Soballe, Peter W / Giambartolomei, Claudia / Mai, Phuong L / Galbo, Claudia E / Nichols, Kathryn / Calzone, Kathleen A / Olopade, Olufunmilayo I / Gail, Mitchell H / Giger, Maryellen L

Breast cancer research : BCR

2014 Volume 16, Issue 4, Page(s) 424

Abstract: Introduction: Mammographic density is similar among women at risk of either sporadic or BRCA1/2-related breast cancer. It has been suggested that digitized mammographic images contain computer-extractable information within the parenchymal pattern, ... ...

Abstract	Introduction: Mammographic density is similar among women at risk of either sporadic or BRCA1/2-related breast cancer. It has been suggested that digitized mammographic images contain computer-extractable information within the parenchymal pattern, which may contribute to distinguishing between BRCA1/2 mutation carriers and non-carriers. Methods: We compared mammographic texture pattern features in digitized mammograms from women with deleterious BRCA1/2 mutations (n = 137) versus non-carriers (n = 100). Subjects were stratified into training (107 carriers, 70 non-carriers) and testing (30 carriers, 30 non-carriers) datasets. Masked to mutation status, texture features were extracted from a retro-areolar region-of-interest in each subject's digitized mammogram. Stepwise linear regression analysis of the training dataset identified variables to be included in a radiographic texture analysis (RTA) classifier model aimed at distinguishing BRCA1/2 carriers from non-carriers. The selected features were combined using a Bayesian Artificial Neural Network (BANN) algorithm, which produced a probability score rating the likelihood of each subject's belonging to the mutation-positive group. These probability scores were evaluated in the independent testing dataset to determine whether their distribution differed between BRCA1/2 mutation carriers and non-carriers. A receiver operating characteristic analysis was performed to estimate the model's discriminatory capacity. Results: In the testing dataset, a one standard deviation (SD) increase in the probability score from the BANN-trained classifier was associated with a two-fold increase in the odds of predicting BRCA1/2 mutation status: unadjusted odds ratio (OR) = 2.00, 95% confidence interval (CI): 1.59, 2.51, P = 0.02; age-adjusted OR = 1.93, 95% CI: 1.53, 2.42, P = 0.03. Additional adjustment for percent mammographic density did little to change the OR. The area under the curve for the BANN-trained classifier to distinguish between BRCA1/2 mutation carriers and non-carriers was 0.68 for features alone and 0.72 for the features plus percent mammographic density. Conclusions: Our findings suggest that, unlike percent mammographic density, computer-extracted mammographic texture pattern features are associated with carrying BRCA1/2 mutations. Although still at an early stage, our novel RTA classifier has potential for improving mammographic image interpretation by permitting real-time risk stratification among women undergoing screening mammography.
MeSH term(s)	Adult ; Aged ; Breast Density ; Breast Neoplasms/diagnosis ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Datasets as Topic ; Female ; Genes, BRCA1 ; Genes, BRCA2 ; Heterozygote ; Humans ; Mammary Glands, Human/abnormalities ; Mammography ; Middle Aged ; Mutation ; Risk Factors ; Sensitivity and Specificity
Language	English
Publishing date	2014-08-23
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/PREACCEPT-1744229618121391
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Article ; Online: Research Priorities, Measures, and Recommendations for Assessment of Tobacco Use in Clinical Cancer Research.

Land, Stephanie R / Toll, Benjamin A / Moinpour, Carol M / Mitchell, Sandra A / Ostroff, Jamie S / Hatsukami, Dorothy K / Duffy, Sonia A / Gritz, Ellen R / Rigotti, Nancy A / Brandon, Thomas H / Prindiville, Sheila A / Sarna, Linda P / Schnoll, Robert A / Herbst, Roy S / Cinciripini, Paul M / Leischow, Scott J / Dresler, Carolyn M / Fiore, Michael C / Warren, Graham W

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

2016 Volume 22, Issue 8, Page(s) 1907–1913

Abstract: There is strong evidence that cigarette smoking causes adverse outcomes in people with cancer. However, more research is needed regarding those effects and the effects of alternative tobacco products and of secondhand smoke, the effects of cessation ( ... ...

Abstract	There is strong evidence that cigarette smoking causes adverse outcomes in people with cancer. However, more research is needed regarding those effects and the effects of alternative tobacco products and of secondhand smoke, the effects of cessation (before diagnosis, during treatment, or during survivorship), the biologic mechanisms, and optimal strategies for tobacco dependence treatment in oncology. Fundamentally, tobacco is an important source of variation in clinical treatment trials. Nevertheless, tobacco use assessment has not been uniform in clinical trials. Progress has been impeded by a lack of consensus regarding tobacco use assessment suitable for cancer patients. The NCI-AACR Cancer Patient Tobacco Use Assessment Task Force identified priority research areas and developed recommendations for assessment items and timing of assessment in cancer research. A cognitive interview study was conducted with 30 cancer patients at the NIH Clinical Center to evaluate and improve the measurement items. The resulting Cancer Patient Tobacco Use Questionnaire (C-TUQ) includes "Core" items for minimal assessment of tobacco use at initial and follow-up time points, and an "Extension" set. Domains include the following: cigarette and other tobacco use status, intensity, and past use; use relative to cancer diagnosis and treatment; cessation approaches and history; and secondhand smoke exposure. The Task Force recommends that assessment occur at study entry and, at a minimum, at the end of protocol therapy in clinical trials. Broad adoption of the recommended measures and timing protocol, and pursuit of the recommended research priorities, will help us to achieve a clearer understanding of the significance of tobacco use and cessation for cancer patients.
MeSH term(s)	Advisory Committees ; Guidelines as Topic ; Humans ; Medical Oncology/methods ; Medical Oncology/standards ; Research/standards ; Risk Assessment ; Tobacco Use/adverse effects
Language	English
Publishing date	2016-02-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-16-0104
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Article ; Online: Recruitment to a physical activity intervention study in women at increased risk of breast cancer

Drinkard Bart / Prindiville Sheila A / Venzon David / Smith Ashley W / Micheli Amy / Korde Larissa A / Sebring Nancy / Smith Marcia D / Zujewski Jo / Eng-Wong Jennifer

BMC Medical Research Methodology, Vol 9, Iss 1, p

2009 Volume 27

Abstract: Abstract Background Physical activity is being studied as a breast cancer prevention strategy. Women at risk of breast cancer report interest in lifestyle modification, but recruitment to randomized physical activity intervention studies is challenging. ... ...

Abstract	Abstract Background Physical activity is being studied as a breast cancer prevention strategy. Women at risk of breast cancer report interest in lifestyle modification, but recruitment to randomized physical activity intervention studies is challenging. Methods We conducted an analysis of recruitment techniques used for a prospective, randomized pilot study of physical activity in women at risk of breast cancer. We evaluated differences in proportion of eligible patients, enrolled patients, and successful patients identified by each individual recruitment method. The Fisher-Freeman-Halton test (an extension of Fisher's exact test from 2 × 2 tables to general row by column tables) was used to compare the success of different recruitment strategies. Results We received 352 inquiries from women interested in participating, of whom 171 (54%) were eligible. Ninety-nine women completed a baseline activity evaluation, and 58 (34% of eligible; 16% of total inquiries) were randomized. Recruitment methods fell into three broad categories: media techniques, direct contact with potential participants, and contacts with health care providers. Recruitment strategies differed significantly in their ability to identify eligible women (p = 0.01), and women who subsequently enrolled in the study (p = 0.02). Conclusion Recruitment techniques had varying success. Our data illustrate the challenges in recruiting to behavior modification studies, and provide useful information for tailoring future recruitment efforts for lifestyle intervention trials. Trial Registration No(s) CDR0000393790, NCI-04-C-0276, NCI-NAVY-B05-001
Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2009-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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