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Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
NCT00005095 · Northwestern University
In plain English
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Official title
Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
About this study
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.
Eligibility criteria
DISEASE CHARACTERISTICS:
* Meets one of the following criteria:
* Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:
* Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
* Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor
* A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer
* Increased risk as deemed by a certified genetic counselor
* Undergoing surgery for a gynecologic condition, including any of the following:
* Diagnosis of a reproductive cancer
* Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)
* Highly suspicious adnexal mass
* Risk-reducing prophylactic oophorectomy
PATIENT CHARACTERISTICS:
Age
* Between the ages of 18 and 80
Study design
Enrollment target: 6000 participants
Age groups: adult, older_adult
Timeline
Starts: 2000-03
Estimated completion: 2040-12
Last updated: 2025-02-28
Interventions
Other: Ca-125Other: screening questionnaire administrationProcedure: Surgery
Primary outcomes
- • The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other (1 year)
Sponsor
Northwestern University · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactTakelia Walker · contact · takelia-watson@northwestern.edu · 3125034802
ContactAnne Grace · contact · anne@northwestern.edu · 312-503-4165
InvestigatorLee P. Shulman, MD · study_chair, Robert H. Lurie Cancer Center
All locations (1)
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityRecruiting
Chicago, Illinois, United States