Multi - Center Database/Registry of Subjects at High Risk for Ovarian or Breast Cancer - A Lynne Cohen Consortium Project
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.
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
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.
Observational Model: Case Control, Time Perspective: Prospective
Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer
Karen H. Lu, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|NYU Cancer Institute||New York, New York 10016|
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|University of Alabama, Birmingham/Department of OB/GYN||Birmingham, Alabama 35233|