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Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

NCT01768156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2020-10-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-24
Primary Completion
2015-09-22
Completion
2016-11-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768156 on ClinicalTrials.gov