Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

June 13, 2023 updated by: Lee Shulman, Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Anne Grace
  • Phone Number: 312-503-4165

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
        • Contact:
          • Clinical Trials Office - Robert H. Lurie Comprehensive Cancer
          • Phone Number: 312-695-1301
          • Email: cancer@northwestern.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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: 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.
Other Names:
  • Questionnaire
Other: Ca-125
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.
Procedure: Surgery
Subjects will be assessed for high risk factors.
Other Names:
  • BSO, fallopian tubes, TAH, hysterectomy, bilateral salpingectomy, STIC
Suspected or diagnosed gynecological condition
Women who are planning to undergo surgery for their gynecological condition
Control Group
Healthy subjects with no history of cancer and at general risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other
Time Frame: 1 year
To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new prevention approaches and therapies for risk assessment
Time Frame: 1 year
To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.
1 year
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
Time Frame: 1 year
To identify the measurements to improve the quality of life for women at increased risk for developing the disease
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Lee P. Shulman, MD, Robert H. Lurie Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 99G8
  • P30CA060553 (U.S. NIH Grant/Contract)
  • NU-99G8 (Other Identifier: Northwestern University IRB)
  • NCI-G00-1753 (Other Grant/Funding Number: NCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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