# Infrastructure Support and Pilot Tissue Collection for the CARET Biorepository

> **NIH NIH U01** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $590,562

## Abstract

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 rel...

## Key facts

- **NIH application ID:** 9882960
- **Project number:** 5U01CA167462-08
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** CHU CHEN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $590,562
- **Award type:** 5
- **Project period:** 2013-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9882960

## Citation

> US National Institutes of Health, RePORTER application 9882960, Infrastructure Support and Pilot Tissue Collection for the CARET Biorepository (5U01CA167462-08). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9882960. Licensed CC0.

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