Status:
NOT_YET_RECRUITING
Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial
Lead Sponsor:
University Hospital, Tours
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05991752
Start Date
November 1 2023
End Date
November 1 2028
Last Update
August 15 2023
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