Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Biological sampling in ovarian carcinoma
Blood and tumor samples
Intervention: biological sampling (Other)
Outcomes
Primary Outcomes
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.
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported