Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
150
Tumor and blood samples
Centre Jean Perrin
Clermont-Ferrand, France
RECRUITINGCentre Oscar Lambret
Lille, France
RECRUITINGInstitut Du Cancer de Montpellier
Montpellier, France
RECRUITINGPrognostic 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
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
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