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

I

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Completed

Conditions

Metastatic Ovarian Cancer

Treatments

Other: Experimental arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01768156
2010-A00152-37 (Registry Identifier)
Meta-Four

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

101 participants in 1 patient group

Study arm
Experimental group
Treatment:
Other: Experimental arm

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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