Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

Metastatic Ovarian Cancer Clinical Trial

— Meta-Four  

Official title:

Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768156
• Other study ID #: Meta-Four
• Secondary ID: 2010-A00152-37
• Status: Completed
• Phase: N/A
• Start date: September 24, 2010
• Est. completion date: November 15, 2016

Study information

• Verified date: October 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 15, 2016
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Metastatic Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	CRLC Val d'Aurelle-Paul Lamarque	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the predictive and prognostic value of HE4 marker		18 months
Secondary	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