Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), April 2007

Sponsored by:	GenBasix Incorporated
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445562

Purpose

RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.

PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Condition	Intervention
Breast Cancer	Procedure: observation

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Breast Cancer Siblings Database

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Collection of blood samples and medical and background information

Estimated Enrollment:	1000
Study Start Date:	January 2001
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.

OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.

Patients and their siblings are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Pathologically confirmed invasive breast cancer (patient)
  - No ductal carcinoma in situ
- Affected OR unaffected sibling
  - Affected sibling must have had (or currently has) breast cancer only
  - Unaffected sibling must be female
  - No deceased siblings
  - Must be a full-blood related sibling
Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445562

Locations

United States, California
GenBasix Incorporated	Recruiting
Duarte, California, United States, 91010
Contact: Richard A. Shapiro, MD 800-248-4908

Sponsors and Collaborators

GenBasix Incorporated

Investigators

Study Chair:

Richard A. Shapiro, MD

GenBasix Incorporated

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000529353, GENBASIX-00127, GENBASIX-1024122
Study First Received:	March 7, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00445562
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

male breast cancer
recurrent breast cancer
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009