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

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ClinicalTrials.gov Identifier: NCT00445562
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 9, 2007
Last Update Posted : July 10, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: biologic sample preservation procedure Other: informational intervention

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Official Title: Breast Cancer Siblings Database
Study Start Date : January 2001
Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Collection of blood samples and medical and background information

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00445562     History of Changes
Other Study ID Numbers: GENBASIX-00127
CDR0000529353 ( Registry Identifier: PDQ (Physician Data Query) )
GENBASIX-1024122
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2009

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