Risk Factor Analysis of Hereditary Breast and Ovarian Cancer

Study ID
STU 112010-059

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern Moncrieff Cancer Center
  • Parkland Health & Hospital System

Contact
Linda Robinson
214-645-2563
linda.robinson@utsouthwestern.edu

Principal Investigator
Theodora Ross

Summary

Subjects who take part in this prospective cohort study will be asked to sign a consent form and complete a baseline questionnaire. This is an anonymous study. all study participants will be assigned a study number. This number will be placed on the questionnaire. a master list of the study patients and their individual study number will be kept in a secure filing cabinet by the project coordinator. We will ask subjects questions regarding their fertility history, breast cancer diagnosis, breast cancer screening and prevention, ovarian cancer, reproductive and abdominal surgeries, ethnic background, and lifestyle choices. a follow up questionnaire will be sent to them every 2 years until 2013. at this time the study will be closed. We would also like to enroll any sisters that do not have the BRCa gene mutation as controls for this study.

Subjects will be provided with a self-addressed envelope to submit their information to the genetic counselors at uT Southwestern Medical Center. Their name will only be on the cover sheet of the questionnaire. once this information is received at uT Southwestern, their name will be removed and they will be assigned a study number. The questionnaire, with only the study number attached will be sent to the Women's College in Toronto, Canada for analysis. The subject's family cancer history information will also be sent with the questionnaire, however all identifying information, such as name and date of birth, will be removed.

about 200 people will take part in this study at uT Southwestern or Parkland Health and Hospital System or Moncrief Cancer Resources. This study is part of a cohort study based out of the Women's College Hospital in Toronto, Canada. There are 28 medical facilities from around the world that are participating in this study. There will be a total of 9000 women participating in this research study throughout the united States and other countries.

Participant Eligibility

Criteria for Inclusion of Subjects:
1. Female
2. Carrier of BRCA1 and BRCA2 mutation
3. Alive at study entry
4. Above the age of 25
5. Spanish-speaking patients are eligible for participation