Studying Normal Breast Tissue and Cancer Risk

Pilot Study to Collect Normal Breast Tissue From Organ and Tissue Donors

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Cancer Institute (NCI), 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Samples of normal breast tissue from organ donors for assessment of histology.@@@@@@

Description

• INCLUSION CRITERIA

The study will enroll girls or women aged 11 years or older.

EXCLUSION CRITERIA

Men are excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Samples of normal breast tissue; Samples of normal breast tissue from organ donors for assessment of histology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological features	descriptive	cross-sectional

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Kononen J, Bubendorf L, Kallioniemi A, Barlund M, Schraml P, Leighton S, Torhorst J, Mihatsch MJ, Sauter G, Kallioniemi OP. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998 Jul;4(7):844-7. doi: 10.1038/nm0798-844.
• Chuaqui RF, Bonner RF, Best CJ, Gillespie JW, Flaig MJ, Hewitt SM, Phillips JL, Krizman DB, Tangrea MA, Ahram M, Linehan WM, Knezevic V, Emmert-Buck MR. Post-analysis follow-up and validation of microarray experiments. Nat Genet. 2002 Dec;32 Suppl:509-14. doi: 10.1038/ng1034.
• Gruvberger S, Ringner M, Chen Y, Panavally S, Saal LH, Borg A, Ferno M, Peterson C, Meltzer PS. Estrogen receptor status in breast cancer is associated with remarkably distinct gene expression patterns. Cancer Res. 2001 Aug 15;61(16):5979-84.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2003
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: June 19, 2006
• First Submitted That Met QC Criteria: June 19, 2006
• First Posted (Estimate): June 21, 2006

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Development; Risk; Genes; Mammary
• Additional Relevant MeSH Terms: Neoplasms; Breast Neoplasms; Skin Diseases; Breast Diseases; Neoplasms by Site
• Other Study ID Numbers: 999903158; 03-C-N158