HE4 as a Relapse Biomarker in Ovarian Cancers (PRONOV4IR)

December 16, 2022 updated by: Institut de Cancérologie de Lorraine

Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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
    • CHU Metz Thionville
      • Metz, CHU Metz Thionville, France, 57085
        • LONGO Raphaelle
    • Centre Georges François Leclerc
      • Dijon, Centre Georges François Leclerc, France, 21 079
        • BENGRINE-LEVEVRE Leïla
    • Centre Paul Strauss
      • Strasbourg, Centre Paul Strauss, France, 67065
        • DEMARCHI Martin
    • Hôpital Civil
      • Strasbourg, Hôpital Civil, France, 67 091
        • KURTZ Jean-Emmanuel
    • Hôpital Jean Minjoz
      • Besançon, Hôpital Jean Minjoz, France, 25 030
        • KALBACHER Elsa
    • Institut De Cancérologie De Lorraine
      • Vandœuvre-lès-Nancy, Institut De Cancérologie De Lorraine, France, 54 519
        • GAVOILLE Céline
    • Institut Jean Godinot
      • Reims, Institut Jean Godinot, France, 51 056
        • SAVOYE Aude-Marie

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
  • Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
  • Age ≥ 18 years .
  • Performance status ECOG > or = 2
  • Adequate haemoglobin rate ≥ 10 g/dL
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation

Exclusion Criteria:

  • Any previous treatment with platinum for ovarian carcinoma
  • Patient with visceral metastases
  • Contraindication for blood test
  • Contraindication for surgery
  • Contraindication for bevacizumab treatment

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

Serum samples are collected:

  • at each neoadjuvant chemotherapy cycle
  • before surgery
  • at each adjuvant chemotherapy cycle
  • at each injection of bevacizumab as maintenance therapy
  • stop at the progression or after 24 months post chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the predictive and prognostic value of HE4 marker
Time Frame: 24 months
Serum concentration of HE4 (pMol) will be analysed at each visit
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the evolution of HE4 and CA-125 serum concentration
Time Frame: 24 months
Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle
24 months
Evaluate the progression-free survival at 18 months
Time Frame: 24 months
HE4 and CA125 will be compared with the rate of progression-free survival
24 months
Evaluate the quality of surgery
Time Frame: 24 months
HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).
24 months

Collaborators and Investigators

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

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: Céline Gavoille, MD, Institut de Cancérologie de Lorraine

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)

April 1, 2016

Primary Completion (Actual)

July 18, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01511-46

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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