NCT00776958

Brief Summary

Goals of this registry: 1.1 To collect and store very limited demographic information (age, birthdate, race and ethnicity), limited cancer risk and breast and ovarian disease history, as well as limited family history of breast and ovarian cancer on patients who are at risk of breast or ovarian cancer or who have had a diagnosis of either cancer, 1.2 To make available summary information (in an anonymous form) regarding the subjects in this registry to Consortium members, and other investigators, who can use these data to plan research projects and evaluate the feasibility of such projects, 1.3 To make available summary information (number of new patients seen in the clinic, number of mutations, number of preventive surgeries, average age of patients seen) to the Lynne Cohen Foundation for Ovarian Cancer Research, in order to document the numbers of subjects who utilize their supported clinics.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

4 active sites

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

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

6 years

First QC Date

October 20, 2008

Last Update Submit

July 30, 2014

Conditions

Keywords

A Lynne Cohen Consortium ProjectMulti-Center Database RegistryHigh RiskCancerBreastBRCA1 or BRCA2 geneOvaryQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer

    9 Years

Secondary Outcomes (1)

  • Establish Repository of Minimal Basic Data (Multicenter Registry)

    9 Years

Study Arms (1)

Ovarian or Breast Cancer Study Registry

Other: Questionnaire

Interventions

Information Collection for Entry into Multicenter Registry: Survey 5-10 minutes. Participation lasts as long as patient agrees to continue having study information collected

Also known as: Survey, Demographics, Data Collection
Ovarian or Breast Cancer Study Registry

Eligibility Criteria

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

Women seen at a member clinic of the Lynne Cohen Consortium having, or at high risk of either ovarian or breast cancer.

You may qualify if:

  • Women who are 18 or older and meet one or more of the following criteria.
  • Personal history of breast and/or ovarian cancer.
  • Family history of breast and/or ovarian cancer (one or more relatives).
  • Carrier of a mutation in the BRCA1 or BRCA 2 gene, or the presence of one of these mutations in a family member.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama, Birmingham/Department of OB/GYN

Birmingham, Alabama, 35233, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

NYU Cancer Institute

New York, New York, 10016, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsBreast NeoplasmsNeoplasmsFanconi Anemia, Complementation Group D1

Interventions

Surveys and QuestionnairesDemographyData Collection

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPopulation CharacteristicsEpidemiologic Measurements

Study Officials

  • Karen H. Lu, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations