HE4 as a Relapse Biomarker in Ovarian Cancers

Study Overview
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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.

Official Title
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Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

Conditions
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Ovarian Carcinoma

Intervention / Treatment
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* Other: Experimental arm


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br> | Other: Experimental arm<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the predictive and prognostic value of HE4 marker | Serum concentration of HE4 (pMol) will be analysed at each visit | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 
| Evaluate the progression-free survival at 18 months | HE4 and CA125 will be compared with the rate of progression-free survival | 24 months | 
| Evaluate the quality of surgery | HE4 and CA125 will be compared with completeness of cancer resection score (CCR score). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker