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

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Other)
• Overall Status: Completed
• CT.gov ID: NCT01768156
• Collaborator: (none)
• Enrollment: 101
• Locations: 2
• Arm: 1
• Actual Duration (Months): 73.7
• Patients Per Site: 50.5
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Ovarian Cancer	Other: Experimental arm	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Sep 24, 2010
• Actual Primary Completion Date: Sep 22, 2015
• Actual Study Completion Date: Nov 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To evaluate the predictive and prognostic value of HE4 marker [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. [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Bergonié	Bordeaux		France	33076
2	CRLC Val d'Aurelle-Paul Lamarque	Montpellier		France	34298

Sponsors and Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• ClinicalTrials.gov Identifier: NCT01768156
• Other Study ID Numbers: Meta-Four; 2010-A00152-37
• First Posted: Jan 15, 2013
• Last Update Posted: Oct 20, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle: ovarian cancer; biomarker; metastatic
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Oct 20, 2020