Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Sponsor

Northwestern University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00005095

Collaborator

National Cancer Institute (NCI) (NIH)

6,000

Enrollment

Location

Study Details

Study Description

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	Intervention/Treatment	Phase
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Ovarian Cancer Sarcoma Uterine Leiomyomata Vaginal Cancer Vulvar Cancer	Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: study of high risk factors

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 Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Time Perspective:

Prospective

Official Title:

Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study

Study Start Date :

Mar 1, 2000

Anticipated Primary Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
High Risk for Ovarian Cancer 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.	Other: laboratory biomarker analysis Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer. Other: screening questionnaire administration Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected. Procedure: study of high risk factors Subjects will be assessed for high risk factors.

Arm

Intervention/Treatment

High Risk for Ovarian Cancer

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.

Other: laboratory biomarker analysis

Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.

Other: screening questionnaire administration

Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.

Procedure: study of high risk factors

Subjects will be assessed for high risk factors.

Outcome Measures

Primary Outcome Measures

Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies [Outcomes will be assessed at the completion of the study.]

Secondary Outcome Measures

Identification of new prevention approaches and therapies [Outcomes will be assessed at the completion of the study.]
Identification of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer [Outcomes will be assessed at the completion of the study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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