Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445562
First received: March 7, 2007
Last updated: November 5, 2010
Last verified: July 2009
History of Changes
  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
 Other: biologic sample preservation procedure
Other: informational intervention

Study Type: Observational
Official Title: Breast Cancer Siblings Database

Resource links provided by NLM:

U.S. FDA Resources

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00445562     History of Changes
Other Study ID Numbers: CDR0000529353, GENBASIX-00127, GENBASIX-1024122
Study First Received: March 7, 2007
Last Updated: November 5, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013