Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-24

Study Completion Date

2016-11-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study arm

Group Type EXPERIMENTAL

Experimental arm

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No