Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial

Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé

In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker assay) will enable faster, more targeted diagnosis and management of epithelial ovarian cancer recurrence than the CA125 marker assay alone. This early identification of recurrence would then improve patients' quality of life, since it would increase the chances of benefiting from less invasive and less morbid surgery. It would also reduce the cost of patient management following disease progression. If our hypothesis is confirmed, the results of this study will enable us to update the recommendations for post-treatment follow-up of patients in remission from epithelial ovarian cancer, as well as reimbursing the HE4 marker assay (and thus the calculation of the ROMA score).

Inclusion Criteria:

• Women aged 18 or over and less than 85 years old
• With proven FIGO stage I to IV epithelial ovarian cancer (ovary/tumor/peritoneum)
• Women in remission after first-line chemotherapy, with a normal CA125 less than 4 months old at study entry (end of first-line chemotherapy).
• Woman having completed chemotherapy at least 6 months previously
• Written informed consent
• French social security

Exclusion Criteria:

• Any physical or psychiatric condition that may interfere with the patient's cooperation in data collection
• Patient with normal CA125 at initial diagnosis of epithelial ovarian cancer
• Patient under guardianship
• Patient deprived of liberty