CIDOC: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Study Details
Study Description
Brief Summary
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biological sampling in ovarian carcinoma Blood and tumor samples |
Other: biological sampling
Tumor and blood samples
|
Outcome Measures
Primary Outcome Measures
- 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. [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]
Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
Eligibility Criteria
Criteria
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:
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Contraindication to surgical assessment.
-
Pathological diagnosis of mucinous carcinoma.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Jean Perrin | Clermont Ferrand | France | 63011 | |
| 2 | Centre Oscar Lambret | Lille | France | 59000 | |
| 3 | Institut Du Cancer de Montpellier | Montpellier | France | 34298 |
Sponsors and Collaborators
- Institut Paoli-Calmettes
- AstraZeneca
Investigators
- Principal Investigator: Renaud SABATIER, MD, Institut Paoli-Calmettes
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CIDOC-IPC- 2016-008