Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Northwestern University

Status: Enrolling

Conditions: Endometrial Cancer; Sarcoma; Vulvar Cancer; Uterine Leiomyomata; Vaginal Cancer; Fallopian Tube Cancer; Ovarian Cancer; Hereditary Breast/Ovarian Cancer (brca1, brca2); Cervical Cancer

Treatments: Other: screening questionnaire administration; Other: Ca-125; Procedure: Surgery

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00005095

NU-99G8

P30CA060553 (U.S. NIH Grant/Contract)

NCI-G00-1753

NU 99G8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

6,000 participants in 3 patient groups

High Risk for Ovarian Cancer

Description:

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.

Treatment:

Procedure: Surgery

Other: Ca-125

Other: screening questionnaire administration

Suspected or diagnosed gynecological condition

Description:

Women who are planning to undergo surgery for their gynecological condition

Control Group

Description:

Healthy subjects with no history of cancer and at general risk.