Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4 (TORCH)

August 30, 2023 updated by: Centre Hospitalier Departemental Vendee

Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)

Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.

To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.

The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

221

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

  • France
      • Cholet, France, 49300
        • Centre Hospitalier de Cholet
      • La Roche sur Yon, France, 85925
        • CHD Vendee
      • Nantes, France, 44093
        • CHU de Nantes
      • Saint Nazaire, France, 44606
        • CH de Saint Nazaire

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

Sampling Method

Non-Probability Sample

Study Population

Patient hospitalized for surgery for presumed benign ovarian tumor

Description

Inclusion Criteria:

  • patients to undergo surgery for an ovarian cyst
  • presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
  • agreement to participate in the study

Exclusion Criteria:

  • pregnant patient
  • minor patient
  • Patient under guardianship, trusteeship, or deprived of liberty
  • Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
  • Patient with an adnexal torsion is suspected
  • Patient unable to understand the proposed study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Marker CA125
Time Frame: Baseline
CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL.
Baseline
Tumor Marker HE4
Time Frame: Baseline

HE4 < 70 pmol/L for premenopausal women or < 140 pmol/L for postmenopausal women

Abnormal score if HE4 > 70 pmol/L for premenopausal women or > 140 pmol/L for postmenopausal women
Baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Director: Guillaume DUCARME, PH, CHD Vendee

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

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimated)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD064-14

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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