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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768156
Recruitment Status : Unknown
Verified March 2015 by Institut du Cancer de Montpellier - Val d'Aurelle.
Recruitment status was:  Recruiting
First Posted : January 15, 2013
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
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.

Condition or disease Intervention/treatment
Metastatic Ovarian Cancer Other: Experimental arm

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
Study Start Date : January 2011
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. To evaluate the predictive and prognostic value of HE4 marker [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768156

Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Anne Floquet, MD    33      
Principal Investigator: Anne Floquet, MD         
CRLC Val d'Aurelle-Paul Lamarque Recruiting
Montpellier, France, 34298
Contact: Jean-Pierre Bleuse, MD    33 4 67 61 23 44   
Principal Investigator: Michel Fabbro, MD         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT01768156     History of Changes
Other Study ID Numbers: Meta-Four
2010-A00152-37 ( Registry Identifier: N° ID RCB )
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders