To hear about similar clinical trials, please enter your email below
Trial Title:
Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial
NCT ID:
NCT05991752
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ROMA score evaluation
Description:
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).
Arm group label:
ROMA Score
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).
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
November 2023
Completion date:
November 2028
Lead sponsor:
Agency:
University Hospital, Tours
Agency class:
Other
Source:
University Hospital, Tours
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991752
