Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Recruiting

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

• Registration Number: NCT00005095
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study Start: 2000-03
• Study First Submitted: 2000-04-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2030-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 6000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other	1 year	To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies

Secondary Outcome Measures

Name	Time	Method
The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer	1 year	To identify the measurements to improve the quality of life for women at increased risk for developing the disease
new prevention approaches and therapies for risk assessment	1 year	To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States