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

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Epithelial Ovarian Cancer

Treatments

Diagnostic Test: ROMA score evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT05991752

DR210313

Details and patient eligibility

About

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).

Enrollment

320 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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