Lynne Cohen Consortium Project: Multi-Center Database/Registry

Breast Cancer Clinical Trial

Official title:

Multi - Center Database/Registry of Subjects at High Risk for Ovarian or Breast Cancer - A Lynne Cohen Consortium Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776958
• Other study ID #: 2008-0067
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: July 30, 2014
• Start date: July 2008

Study information

• Verified date: July 2014
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Information Collection for Entry into Multicenter Registry:

If you agree to take part in this study, a study staff member will collect the following information by asking you at a clinic visit and checking your medical records. The following information will be entered in the registry:

your demographic information (your sex, year of birth, and race/ethnicity) whether any member of your family has a history of ovarian and/or breast cancer whether any member of your family has any known genetic markers that may mean a higher risk of developing a cancer a brief summary of your history of breast and/or ovarian disease and whether you have any known genetic markers that may mean a higher risk of developing breast and/or ovarian cancer a brief summary of the results of the clinic visit on the day you agreed to take part in this study (Day 1)

Follow-Up Information Collection:

Each time you visit the M. D. Anderson high-risk clinic (either the high-risk breast cancer clinic or the high-risk ovarian cancer clinic), the study staff will check your medical records and enter in the registry any updates to your cancer risk information. You will also be asked if any family members have been diagnosed with ovarian and/or breast cancer, and this will be entered in the registry.

If you miss any of your planned clinic visits, the study staff may contact you by phone to collect this information, contact you by mail to send you a questionnaire with this information, and/or reschedule your appointment. If you receive a questionnaire by mail, you will fill it out and mail it back to the research staff in the stamped, self-addressed envelope that will be provided to you. It should take about 5-10 minutes to complete.

Study Data:

The study staff plans to keep all personal identifying information (such as your name) strictly confidential. Your data will be handwritten on paper forms that will be stored in a locked file cabinet. The study staff will enter your data into the multicenter database (registry) with your participant identification (ID) number but not your name or other identifying information. The registry is password-protected. Only designated members of the study staff will have access to the participant ID numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. The linking information will be saved securely (on a password-protected computer) in the research office.

The multicenter registry is called the Lynne Cohen registry. It is maintained at the University of Southern California Norris Comprehensive Cancer Center.

Use of Registry for Planning Future Research:

Lynne Cohen clinics make up the multicenter group of clinics that are involved in this study. If a researcher at any Lynne Cohen clinic is planning to perform a research study involving ovarian or breast cancer causes or prevention, he or she can contact the Lynne Cohen Foundation. A staff member at the Lynne Cohen Foundation will check to see how many patients are included in the registry. This will help the researcher find out how many people the researcher may be able to ask to join his or her study. That number of people will also help the researcher decide if the planned study is feasible. The number of patients in the registry is the only information that will be shared with these researchers.

Length of Study Participation:

Your participation in this study will last for as long as you agree to keep having this study information collected.

When your participation in this study ends, the M. D. Anderson study staff will delete or destroy any personal identifying information and contact information collected. The rest of the study data will continue being stored in the registry.

This is an investigational study.

Up to 1000 patients will be enrolled in this multicenter study. Up to 200 will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham/Department of OB/GYN	Birmingham	Alabama
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	NYU Cancer Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Lynne Cohen Foundation for Ovarian Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer		9 Years	No
Secondary	Establish Repository of Minimal Basic Data (Multicenter Registry)		9 Years	No

External Links

•   University of Texas MD Anderson Cancer Center Website