NCT01380925

Brief Summary

The research team is studying why some African American families have multiple cases of breast cancer. This study will help to better understand if there are undiscovered genes unique to African Americans that may predict early breast cancer risk. Breast cancer survivors AND their relatives who are also breast cancer survivors are being recruited to the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

June 22, 2011

Last Update Submit

May 10, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • breast cancer

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American breast cancer survivors.

You may qualify if:

  • Black/African American
  • Ever diagnosed with breast cancer
  • Have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate
  • Live in the U.S.

You may not qualify if:

  • Tested positive for BRCA mutations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214-8001, United States

Location

Related Publications (1)

  • Ochs-Balcom HM, Sun X, Chen Y, Barnholtz-Sloan J, Erwin DO, Jandorf L, Sucheston-Campbell L, Elston RC. Putative linkage signals identified for breast cancer in African American families. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):442-7. doi: 10.1158/1055-9965.EPI-14-1131. Epub 2014 Dec 4.

    PMID: 25477366RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)