Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Screening may help doctors find ovarian cancer sooner, when it may be easier to treat. It may also help doctors plan better treatment for ovarian cancer.

PURPOSE: This clinical trial is studying screening methods for identifying women who are at increased risk for developing ovarian cancer.

Further Study Information

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: Patients complete an extensive personal and family medical history questionnaire and meet with a genetic counselor to review the questionnaire and for a risk assessment at baseline. Patients also undergo transvaginal ultrasound, clinical breast, pelvic, and rectal exam, and CA-125 testing at baseline and then every 6 months thereafter, or as determined by the physician. Patients also complete additional questionnaires periodically.

Patients undergo blood sample collection periodically for research studies, including molecular, biochemical, functional, and genetic marker studies.

The referring physician will be notified of any abnormal test results. 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

• Asymptomatic AND considered to be at increased risk for developing ovarian cancer, as defined by one of the following:

• Personal history of breast or colon cancer

• Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer

• Has a personal or family history of hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)

• Has at least two family members with breast, ovarian, primary peritoneal, fallopian tube, uterine, and/or pancreatic cancer

• 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

• 18 and over

Trial Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Lee P. Shulman

Study Chair

U.S.A.
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer	Ph: 312-695-1301
			Email: cancer@northwestern.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00005095
Information obtained from ClinicalTrials.gov on December 14, 2011

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