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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01768156
First received: January 9, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Metastatic Ovarian Cancer
Other: Experimental arm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring

Resource links provided by NLM:


Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • To evaluate the predictive and prognostic value of HE4 marker [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768156

Locations
France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Anne Floquet, MD    33 5.56.33.32.46      
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    Jean-pierre.bleuse@montpellier.unicancer.fr   
Principal Investigator: Michel Fabbro, MD         
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT01768156     History of Changes
Other Study ID Numbers: Meta-Four, 2010-A00152-37
Study First Received: January 9, 2013
Last Updated: February 4, 2014
Health Authority: France: French National Ethics Committee

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
ovarian cancer
biomarker
metastatic

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

ClinicalTrials.gov processed this record on July 29, 2014