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

NCT ID: NCT05991752

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2028-11-30

Brief Summary

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).

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ROMA Score

Experimental group: CA125 and HE4 assays every 4 months for 3 years to assess the ROMA score, in addition to the recommended conventional follow-up.

Group Type: EXPERIMENTAL

ROMA score evaluation

Intervention Type: DIAGNOSTIC_TEST

Every 4 months, for 3 years, patients in the experimental group will done a biological examination based on assessment of the ROMA score (CA125+HE4 assay).

CA125 alone

Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ROMA score evaluation

Every 4 months, for 3 years, patients in the experimental group will done a biological examination based on assessment of the ROMA score (CA125+HE4 assay).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DR210313

Identifier Type: -

Identifier Source: org_study_id