NCT00445562

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2009

Enrollment Period

3.9 years

First QC Date

March 7, 2007

Last Update Submit

July 9, 2013

Conditions

Breast Cancer

Keywords

male breast cancerrecurrent breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Collection of blood samples and medical and background information

Interventions

biologic sample preservation procedureOTHER
informational interventionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GenBasix Incorporated

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Richard A. Shapiro, MD

    GenBasix Incorporated

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

January 1, 2001

Primary Completion

December 1, 2004

Last Updated

July 10, 2013

Record last verified: 2009-07

Locations

US(1)