HE4 as a Relapse Biomarker in Ovarian Cancers

Institut de Cancérologie de Lorraine90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Carcinoma

Interventions

Experimental armOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

BENGRINE-LEVEVRE Leïla

Dijon, Centre Georges François Leclerc, France

DEMARCHI Martin

Strasbourg, Centre Paul Strauss, France

LONGO Raphaelle

Metz, CHU Metz Thionville, France

KURTZ Jean-Emmanuel

Strasbourg, Hôpital Civil, France

Outcomes

Primary Outcomes

To evaluate the predictive and prognostic value of HE4 marker

Serum concentration of HE4 (pMol) will be analysed at each visit

Time frame: 24 months

Secondary Outcomes

Compare the evolution of HE4 and CA-125 serum concentration

Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle

Time frame: 24 months

Evaluate the progression-free survival at 18 months

HE4 and CA125 will be compared with the rate of progression-free survival

Time frame: 24 months

Evaluate the quality of surgery

HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).

Time frame: 24 months

Data from ClinicalTrials.gov

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