NCT01768156

Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Ovarian Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-09-24
• Primary completion: 2015-09-22
• Completion: 2016-11-15
• First posted: 2013-01-15
• Last updated: 2020-10-20

Locations

2 sites across 1 country: France