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Lynne Cohen Consortium Project: Multi-Center Database/Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00776958
First received: October 20, 2008
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Ovarian Cancer
Breast Cancer
 Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multi - Center Database/Registry of Subjects at High Risk for Ovarian or Breast Cancer - A Lynne Cohen Consortium Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Establish Repository of Minimal Basic Data (Multicenter Registry) [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ovarian or Breast Cancer Study Registry Other: Questionnaire
Information Collection for Entry into Multicenter Registry: Survey 5-10 minutes. Participation lasts as long as patient agrees to continue having study information collected
Other Names:
  • Survey
  • Demographics
  • Data Collection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1) None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776958

Locations
United States, Alabama
University of Alabama, Birmingham/Department of OB/GYN
Birmingham, Alabama, United States, 35233
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen H. Lu, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00776958     History of Changes
Other Study ID Numbers: 2008-0067
Study First Received: October 20, 2008
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
A Lynne Cohen Consortium Project
Multi-Center Database Registry
High Risk
Cancer
 Breast
BRCA1 or BRCA2 gene
Ovary
Questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 22, 2013