Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

Study Overview
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Brief Summary
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Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Detailed Description
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The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse. Prospective multicentre open-label study During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy. Patients will then have a standard care follow-up for a period of 5 years.

Official Title
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Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

Conditions
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Ovarian Carcinoma

Intervention / Treatment
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* Other: biological sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy. Indication of preoperative and/or adjuvant chemotherapy. Age ≥ 18 years old. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen Signed written informed consent prior to any screening procedures being performed Non inclusion Criteria: Contraindication to surgical assessment. Pathological diagnosis of mucinous carcinoma. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer). Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol. Patient in urgency situation, adult under legal protection, or unable to give his consent. Exclusion Criteria after histological exam: Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological sampling in ovarian carcinoma<br>Blood and tumor samples | Other: biological sampling<br>* Tumor and blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse. | Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir | at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years |