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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

March 7, 2007
November 5, 2010
January 2001
December 2004   (final data collection date for primary outcome measure)
Collection of blood samples and medical and background information
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Complete list of historical versions of study NCT00445562 on ClinicalTrials.gov Archive Site
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Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters
Breast Cancer Siblings Database

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.

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.
Observational
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Breast Cancer
  • Other: biologic sample preservation procedure
  • Other: informational intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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December 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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United States
 
NCT00445562
CDR0000529353, GENBASIX-00127, GENBASIX-1024122
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GenBasix Incorporated
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Study Chair: Richard A. Shapiro, MD GenBasix Incorporated
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP