Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
NCT ID: NCT00005095
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2000-03-31
2040-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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High Risk for Ovarian Cancer
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.
Ca-125
Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
screening questionnaire administration
Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
Surgery
Subjects will be assessed for high risk factors.
Suspected or diagnosed gynecological condition
Women who are planning to undergo surgery for their gynecological condition
No interventions assigned to this group
Control Group
Healthy subjects with no history of cancer and at general risk.
No interventions assigned to this group
Interventions
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Ca-125
Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
screening questionnaire administration
Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
Surgery
Subjects will be assessed for high risk factors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Lee Shulman
Professor
Principal Investigators
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Lee P. Shulman, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Office - Robert H. Lurie Comprehensive Cancer
Role: primary
Related Links
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Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Research
Other Identifiers
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NU-99G8
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G00-1753
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NU 99G8
Identifier Type: -
Identifier Source: org_study_id
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