Risk of Ovarian Cancer in Patients With a Pelvic Mass

November 7, 2011 updated by: Fujirebio Diagnostics, Inc.

Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.

The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Pelvic Mass study is a prospective, multi-center, double blind, statistically powered clinical trial that will enroll female subjects ≥18 years of age presenting to a gynecologist or gynecological oncologist with a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass) who are scheduled to undergo surgery.

The serum tumor marker CA125 has been the most widely used marker in ovarian cancer, however, it is not sufficiently sensitive or specific for the detection of early stage disease. The levels of soluble mesothelin related peptides (SMRP) and HE4 have also recently been found to be elevated in women with ovarian cancer. The results of a pilot study suggest that the use of HE4 may improve the sensitivity of CA125 and provide for stratification of patients presenting with a pelvic mass into high, intermediate and low risk groups.

HE4 and CA125 serum levels will be evaluated in this study for their ability to stratify patients presenting with a pelvic mass into risk groups with low, intermediate or high probabilities of harboring an ovarian cancer at the time of initial presentation. The algorithm using these two serum markers to stratify patients that was developed using pilot study data will be evaluated in this prospective multicenter pelvic mass study. We will also evaluate the inclusion of additional biomarkers and risk factors, such as ultrasound score, age, and menopausal status, into the algorithm to see if there is any improvement in the stratification of patients into the risk groups.

The primary objective of the study is to estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with pelvic mass. Multiple serum biomarkers (CA125 and HE4) will be evaluated to estimate the risk that the patient is harboring an ovarian cancer at the time of presentation.

The secondary objective of the study is to develop a multivariate predictive algorithm combining CA125 and HE4 with radiological imaging results, and patient risk factors (such as age, menopausal status and ethnicity) to estimate the risk of ovarian cancer, including low malignant potential (LMP) / borderline tumors, at the time of surgery in patients presenting with a pelvic mass.

The exploratory endpoints will include the evaluation of serum, plasma and/or urine levels of CA125, HE4 and other additional novel biomarkers such as SMRP, alone and in combination with radiological imaging results and subject risk factors to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass.

Study Type

Observational

Enrollment (Actual)

566

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Fujirebio Diagnostics, Inc
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Richard Moore

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women undergoing surgery for the removal of a pelvic mass.

Description

Inclusion Criteria:

  • Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass);
  • Pre- and post-menopausal women greater than or equal to 18 years of age;
  • Pelvic mass must be demonstrated by ultrasound
  • Able to understand and sign Informed Consent

Exclusion Criteria:

  • Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years
  • Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate
  • Subjects with previous bilateral oophorectomy
  • Any subject known to be pregnant

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
Postmenopausal women
Device: Biomarker Assay (CA125 and HE4)
Premenopausal women
Device: Biomarker Assay (CA125 and HE4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cancer vs Benign Disease

Collaborators and Investigators

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

Sponsor

Fujirebio Diagnostics, Inc.

Investigators

  • Principal Investigator: Richard Moore, M.D., Womens and Infant's Hosapital of Rhode Island

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.

General Publications

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

December 1, 2005

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (ESTIMATE)

April 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDI-03 Pelvic Mass Study

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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