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Clinical Trials (PDQ®)

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, ScreeningActive18 and overNCI, OtherNU 99G8
P30CA060553, NCI-G00-1753, NU-99G7, NCT00005095

Trial Description

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.

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: 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.

Eligibility 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 Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

National Cancer Institute

Lee P. ShulmanStudy Chair

Trial Sites

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
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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