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

Breast Cancer Clinical Trial

Official title:

Breast Cancer Siblings Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00445562
• Other study ID #: GENBASIX-00127
• Secondary ID: CDR0000529353GEN
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2007
• Last updated: July 9, 2013
• Start date: January 2001

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• biologic sample preservation procedure

• informational intervention

Locations

Country	Name	City	State
United States	GenBasix Incorporated	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
GenBasix Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood samples and medical and background information