Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
- Conditions
- Endometrial CancerSarcomaVulvar CancerCervical CancerFallopian Tube CancerOvarian CancerUterine LeiomyomataHereditary Breast/Ovarian Cancer (brca1, brca2)Vaginal Cancer
- Interventions
- Other: Ca-125Other: screening questionnaire administrationProcedure: Surgery
- Registration Number
- NCT00005095
- Lead Sponsor
- Northwestern University
- Brief Summary
RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
- Detailed Description
OBJECTIVES:
* To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
* To identify new prevention approaches and therapies.
* To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.
OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.
The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.
Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 6000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High Risk for Ovarian Cancer Ca-125 Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic. High Risk for Ovarian Cancer screening questionnaire administration Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic. High Risk for Ovarian Cancer Surgery Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic.
- Primary Outcome Measures
Name Time Method The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other 1 year To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies
- Secondary Outcome Measures
Name Time Method The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer 1 year To identify the measurements to improve the quality of life for women at increased risk for developing the disease
new prevention approaches and therapies for risk assessment 1 year To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.
Trial Locations
- Locations (1)
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States