Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer (Meta-Four)

October 16, 2020 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring

HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

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
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle-Paul Lamarque

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

Description

Inclusion Criteria:

  • Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
  • Recurrence of anytime necessitating a new line of chemotherapy
  • Patient having received adjuvant chemotherapy
  • Informed consent signed prior any study specific procedures

Exclusion Criteria:

  • More than 3 lines of chemotherapy
  • Pregnancy or breastfeeding
  • History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
  • Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study arm
Other: Experimental arm

Serum samples are collected:

  • at time of diagnosis of recurrence (before 1st chemotherapy)
  • during each cycle of chemotherapy
  • after the end of chemotherapy
  • every 3 month until treatment failure (3-6 samples)
  • stop at the progression or after 18 months post chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the predictive and prognostic value of HE4 marker
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

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 (ACTUAL)

September 24, 2010

Primary Completion (ACTUAL)

September 22, 2015

Study Completion (ACTUAL)

November 15, 2016

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (ESTIMATE)

January 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meta-Four
  • 2010-A00152-37 (REGISTRY: N° ID RCB)

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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