Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

Not Applicable

Completed

• Conditions: Metastatic Ovarian Cancer
• Interventions: Other: Experimental arm

• Registration Number: NCT01768156
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-24
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Primary Completion: 2015-09-22
• Study Completion: 2016-11-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Experimental arm	-

Primary Outcome Measures

Name	Time	Method
To evaluate the predictive and prognostic value of HE4 marker	18 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CRLC Val d'Aurelle-Paul Lamarque; 🇫🇷 Montpellier, France

Institut Bergonié; 🇫🇷 Bordeaux, France