Studying Normal Breast Tissue and Cancer Risk

Completed

• Conditions: Neoplasms by Site; Skin Diseases; Breast Diseases; Breast Neoplasms; Neoplasms

• Registration Number: NCT00341692
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Breast cancer is the most common cancer among women in the United States. Breast cancer research has been hampered by the difficulty in collecting normal breast tissue. In this study, researchers will obtain samples of normal breast tissue from organ donors and will collect risk-factor data from next-of-kin.

The purpose of this study is to learn how normal breast develops and responds to stresses that are known to increase a woman s chance of developing breast cancer.

Following the breast-tissue donation from 20 volunteers, surgical technicians will make small incisions in the skin and tissue of the breast and remove several samples measuring about one-inch. Technicians also will take samples of the uterine lining to estimate the date of the last menstrual period. The tissue will then be sent to the National Cancer Institute for laboratory research studies. Steps will be taken to ensure that the identity of the participants remains confidential.

Detailed Description

This pilot project, funded by a Breast Cancer Faculty Infrastructure Award, would determine the feasibility of obtaining samples of normal breast tissue from organ donors and collecting risk factor data from next-of-kin. The underlying goal of this initiative is to determine the associations between stages of breast development, risk factors for breast cancer, and gene expression. The study investigators are members of DCEG, CCR and the Transplant Resource Center of Maryland (TRC), a non-profit organization certified by HCFA and the state that processes most organ and tissue donations in Maryland. Trained staff or social workers employed by TRC who routinely obtain consent for donation from next-of-kin will also obtain consent for this study. The existing consent form for organ or tissue donation also includes informed consent for donation of tissue for research. Following organ procurement from 20 volunteers, trained surgical technicians employed by TRC who routinely assist intra-operatively, will sterilely remove tissue from each breast quadrant and split the samples; one portion will be embedded in OCT and snap frozen in liquid nitrogen and the other fixed in 10% buffered formalin. Samples of adipose tissue, blood, urine and endometrium (for menstrual dating) will also be obtained. MES in conjunction with SMH and BKV will assess the samples histopathologically and determine the quantity and quality of macromolecules (RNA, DNA, protein) contained within the tissues. Pending demonstration of the feasibility of this general approach, we will pursue additional funding for a larger study with optimized procedures. We have stopped recruiting patients.

Study Timeline

• Study Start: 2003-04-07
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Primary Completion: 2012-02-01
• Status Verified: 2020-04
• Study Completion: 2020-04-28
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological features	cross-sectional	descriptive

Trial Locations

Locations (1)

National Cancer Institute (NCI), 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States