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

Primary Purpose

Metastatic Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental arm
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Ovarian Cancer focused on measuring ovarian cancer, biomarker, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Institut Bergonié
  • CRLC Val d'Aurelle-Paul Lamarque

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the predictive and prognostic value of HE4 marker

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.

Full Information

First Posted
January 9, 2013
Last Updated
October 16, 2020
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT01768156
Brief Title
Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer
Acronym
Meta-Four
Official Title
Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 24, 2010 (Actual)
Primary Completion Date
September 22, 2015 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Ovarian Cancer
Keywords
ovarian cancer, biomarker, metastatic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Experimental arm
Intervention Description
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 Measure Information:
Title
To evaluate the predictive and prognostic value of HE4 marker
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CRLC Val d'Aurelle-Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

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