HE4 as a Relapse Biomarker in Ovarian Cancers

NCT ID: NCT02595281

Last Updated: 2022-12-19

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2022-07-18

Brief Summary

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HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

Detailed Description

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Conditions

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Ovarian Carcinoma

Keywords

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Ovarian Carcinoma neoadjuvant ROMA Ca125 HE4 biomarker

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 each neoadjuvant chemotherapy cycle
* before surgery
* at each adjuvant chemotherapy cycle
* at each injection of bevacizumab as maintenance therapy
* stop at the progression or after 24 months post chemotherapy

Interventions

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Experimental arm

Serum samples are collected:

* at each neoadjuvant chemotherapy cycle
* before surgery
* at each adjuvant chemotherapy cycle
* at each injection of bevacizumab as maintenance therapy
* stop at the progression or after 24 months post chemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
* Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
* Age ≥ 18 years .
* Performance status ECOG \> or = 2
* Adequate haemoglobin rate ≥ 10 g/dL
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria

* Any previous treatment with platinum for ovarian carcinoma
* Patient with visceral metastases
* Contraindication for blood test
* Contraindication for surgery
* Contraindication for bevacizumab treatment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline Gavoille, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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GAVOILLE Céline

Vandœuvre-lès-Nancy, Institut de Cancérologie de Lorraine, France

Site Status

SAVOYE Aude-Marie

Reims, Institut Jean Godinot, France

Site Status

BENGRINE-LEVEVRE Leïla

Dijon, Centre Georges François Leclerc, France

Site Status

DEMARCHI Martin

Strasbourg, Centre Paul Strauss, France

Site Status

LONGO Raphaelle

Metz, CHU Metz Thionville, France

Site Status

KURTZ Jean-Emmanuel

Strasbourg, Hôpital Civil, France

Site Status

KALBACHER Elsa

Besançon, Hôpital Jean Minjoz, France

Site Status

Countries

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France

Other Identifiers

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2014-A01511-46

Identifier Type: -

Identifier Source: org_study_id