NCT01034033

Brief Summary

The purpose of this study is to try to understand the biology of development of breast, ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk for these diseases. The influence of environmental factors on cancer development in individuals and families will be studied. The efficacy of treatments for these diseases will be evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,300

participants targeted

Target at P75+ for all trials

Timeline
884mo left

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress25%
Aug 2001Jan 2099

Study Start

First participant enrolled

August 1, 2001

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
89.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2099

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

97.5 years

First QC Date

December 16, 2009

Last Update Submit

May 1, 2025

Conditions

Breast CancerOvarian CancerGynecologic CancersOvarian/Peritoneal/Fallopian Cancer

Keywords

quality of life

Eligibility Criteria

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

Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.

You may qualify if:

  • I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and breast tissues

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • James M Ford

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Mills

CONTACT

(650) 724-5223bluett@stanford.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

August 1, 2001

Primary Completion (Estimated)

January 1, 2099

Study Completion (Estimated)

January 1, 2099

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)