Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

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.

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