Clinical trial NCT05991752: Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial
Official title: Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QALY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
timeFrame: 36 months
Secondary outcomes:
measure: Incremental Cost-Effectiveness Ratio (ICER) expressed as the cost per life-year gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
timeFrame: 36 months
measure: Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QAPFY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
timeFrame: 36 months
measure: Financial impact per year and over a 5-year period of spreading the use of the ROMA score in the routine follow-up of patients for the diagnosis of the first recurrence of epithelial ovarian cancer.
timeFrame: per year and over a 5-year period
measure: Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
timeFrame: 36 months
measure: Characteristics of treatments for first recurrence (including surgery)
timeFrame: 36 months
measure: Quality of life of women
timeFrame: 36 months
measure: Evolution of CA125, HE4 and ROMA score after management of the first recurrence
timeFrame: 36 months
measure: Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.
timeFrame: 36 months
Other outcomes:
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