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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
biologic sample preservation procedure
informational intervention
Sponsored by
GenBasix Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GenBasix IncorporatedRecruiting

Outcomes

Primary Outcome Measures

Collection of blood samples and medical and background information

Secondary Outcome Measures

Full Information

First Posted
March 7, 2007
Last Updated
July 9, 2013
Sponsor
GenBasix Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00445562
Brief Title
Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters
Official Title
Breast Cancer Siblings Database
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GenBasix Incorporated

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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

7. Study Design

Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
biologic sample preservation procedure
Intervention Type
Other
Intervention Name(s)
informational intervention
Primary Outcome Measure Information:
Title
Collection of blood samples and medical and background information

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A. Shapiro, MD
Organizational Affiliation
GenBasix Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
GenBasix Incorporated
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard A. Shapiro, MD
Phone
800-248-4908

12. IPD Sharing Statement

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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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