NCT01167842

Brief Summary

This study will analyze tumor tissue from patients with known genetic mutations (BRCA1, BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either primary/recurrent, or two different anatomical sites.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

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, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

11.4 years

First QC Date

July 20, 2010

Last Update Submit

February 2, 2022

Conditions

Breast CancerOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Analysis of Inherited Cancers

    up to 10 years

Eligibility Criteria

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

Primary care clinic, Cancer center, University medical center

You may qualify if:

  • Male or female
  • Age 18 or older
  • documented mutation in BRCA1, BRCA2 or other known cancer causing gene
  • one or more cancer with available stored tissue blocks or slides
  • willing to donate 16cc of blood
  • able to understand English and provide informed consent

You may not qualify if:

  • unable or unwilling to provide informed consent
  • patient does not have tissue blocks available
  • minor, under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect blood as a source for DNA from lymphocytes as well as tumor blocks as a source for tumor DNA

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

  • Elizabeth M Swisher, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Obstetrics & Gynecology

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 22, 2010

Study Start

October 1, 2009

Primary Completion

February 9, 2021

Study Completion

January 14, 2022

Last Updated

February 3, 2022

Record last verified: 2022-02

Locations

US(1)