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Infrastructure Support and Pilot Tissue Collection for the CARET Biorepository

CARET 生物样本库的基础设施支持和试点组织采集

基本信息

批准号：
9882960
负责人：
CHU CHEN
金额：
$ 59.06万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-04-01 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9882960
关键词：
All-Trans-Retinol Asbestos Award Beta Carotene Biocompatible Materials Biological Biological Markers Biological Specimen Banks Biopsy California Cancer Prevention Trial Cardiovascular Diseases Carotene Cause of Death Cessation of life Characteristics Cigarette Smoker Clinical Clinical Data Collection Colon Carcinoma Connecticut Consent DNA Data Databases Development Diagnosis Diagnostic Diagnostic Neoplasm Staging Diet Disease Early Diagnosis Endpoint Determination Enrollment Etiology Exposure to Funding Funding Mechanisms Goals Government Grant Human Resources Incidence Infrastructure Intervention Intervention Trial Investigation Laboratories Life Style Maintenance Malignant Neoplasms Malignant neoplasm of lung Malignant neoplasm of prostate Malignant neoplasm of urinary bladder Medical Records Micronutrients Minerals Molecular Epidemiology Occupational Exposure Operative Surgical Procedures Parents Participant Peer Review Persons Phase Plasma Population Populations at Risk Positioning Attribute Prevention Procedures Publications Publishing Randomized Records Research Research Personnel Resected Resources Safety Sampling Schedule Serum Site Smoking History Specimen Stage at Diagnosis Structure of parenchyma of lung Time Tissue Banks Tissue Sample Tissues Tobacco Tumor Tissue Twin Multiple Birth United States National Institutes of Health Update Vitamins Washington Whole Blood Woman biobank cancer diagnosis cancer epidemiology cancer prevention cigarette smoking cohort cost data sharing double-blind placebo controlled trial early detection biomarkers editorial efficacy trial follow-up genetic analysis genetic epidemiology high risk high risk population improved indexing intervention effect malignant breast neoplasm men molecular subtypes mortality neoplasm registry nutrition nutritional epidemiology outcome forecast personalized medicine post intervention recruit repository research and development retinyl palmitate tobacco abuse tool tumor tumor heterogeneity web site

项目摘要

Project Summary The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 mg of β-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk for lung cancer. The trial began recruitment in 1985 and was halted in January 1996, 21 months ahead of schedule, with the twin conclusions of no benefit and substantial evidence of a harmful effect of the intervention on both lung cancer incidence and total mortality. Participants continued to be followed for over nine years post-intervention, with updated lung cancer incidence and cardiovascular disease mortality findings published in 2004. On June 30, 2005, CARET stopped active follow- up of participants. During the active intervention phase of CARET, serum, plasma, whole blood (for DNA), and lung tissue specimens were collected. These biospecimens make up the CARET biorepository, which is the focus of this application. The CARET biorepository is a key tool in studying disease development and progression. It is an invaluable legacy of the parent trial with specimens available to any investigator with a hypothesis-driven project. The specific aims of the current grant cycle (2013-2018) included extending the database and online accessibility to include participant use of micronutrient, mineral, and vitamin supplements; baseline laboratory values; and stage at diagnosis of lung, prostate, colon, and breast cancer cases. We also extended CARET follow-up of cancer diagnoses, deaths, and causes of death through 2012/13 via linkages to the National Death Index, Cancer Registry of Connecticut, and the Cancer Registries of California and Washington. This has greatly increased the total numbers of identified incident cancer cases (n=6,773) as well as extending the follow-up of the entire cohort (median follow-up to first diagnosis is 18 years and to death is 20 years). In our goal to make the CARET biorepository accessible, during the current grant cycle (2013 – 2018), biospecimens and /or data have been provided to investigators, which have resulted in 23 peer-reviewed publications. Currently there are 93 ongoing projects utilizing CARET biospecimens. In this application, we request funds to continue support of the CARET biorepository and the associated extensive database. We also propose to pilot procedures to obtain updated signed releases of medical records and consent for the utilization of biologic material in the CARET biorepositories consistent with recent developments on obtaining consent for broad research purposes and data sharing. In addition, to position CARET for studies examining the association of tumor heterogeneity and molecular subtypes with etiologic factors and survival, we propose to conduct a pilot to obtain diagnostic lung cancer biopsy/surgical specimens from Washington State CARET participants diagnosed after 2003. This will include obtaining updated release of medical records and consent for broad research purposes and data sharing.

项目总结