evaluation of cancer risk factors
ProcedureAncillary studies
Other names: cancer risk factors evaluation
NCT Number: NCT01139957
This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.
Looking for future studies?
Notify Me30 year and older
Female
Observational
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
PRIMARY OBJECTIVES:
I. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.
II. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.
III. To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.
V. To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).
OUTLINE: This is a multicenter study.
Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ancillary studies
Other names: cancer risk factors evaluation
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Ancillary studies
Time frame: Up to 5 years
Time frame: Up to 5 years
Cox proportional hazards models will be used to compare the incidence rates between the risk-reducing salpingo-oophorectomy (RRSO) and screening groups, adjusting for appropriate covariates. If necessary, modeling will be carried out in order to use non-proportional hazards models.
Time frame: Up to 5 years
Time frame: Up to 5 years
Gynecologic Oncology Group
Network
Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04257045
Adnexal Diseases, Breast Carcinoma
Birmingham, Alabama, United States
View Trial DetailsNCT07285044
Adenocarcinoma, Adnexal Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT03604315
Adnexal Diseases, Breast Carcinoma
Houston, Texas, United States
View Trial DetailsNCT03517488
Adenocarcinoma, Adenoma
Los Angeles, California, United States
View Trial Details