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NCT00005095 | RECRUITING | Cervical Cancer

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
Sponsor:

Northwestern University

Information provided by (Responsible Party):

Lee Shulman

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.

Condition or disease

Cervical Cancer

Endometrial Cancer

Fallopian Tube Cancer

Hereditary Breast/Ovarian Cancer (brca1, brca2)

Ovarian Cancer

Sarcoma

Uterine Leiomyomata

Vaginal Cancer

Vulvar Cancer

Intervention/treatment

Ca-125

screening questionnaire administration

Surgery

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 6000 participants
Official Title : Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
Actual Study Start Date : 2000-03
Estimated Primary Completion Date : 2030-12
Estimated Study Completion Date : 2040-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Location Details

NCT00005095

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How to Participate

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Locations

RECRUITING

United States, Illinois

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States, 60611-3013