Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial
ROMECO
Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé
1 other identifier
interventional
320
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
August 15, 2023
August 1, 2023
5 years
August 7, 2023
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
QALYs (Quality-Adjusted Life Years) will be estimated from patient responses to the EQ-5D-5L instrument (EuroQol group - 5 Dimensions - 5 levels). The cost evaluation will identify, measure and value all the resources consumed in the production of overall care: hospital and outpatient care, transport, informal care, and social aid services. All consumed resources will be estimated from the collective perspective. QALY and cost data will be used to estimate this within-trial ICUR.
36 months
Secondary Outcomes (8)
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.
36 months
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.
36 months
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.
per year and over a 5-year period
Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
36 months
Characteristics of treatments for first recurrence (including surgery)
36 months
- +3 more secondary outcomes
Study Arms (2)
ROMA Score
EXPERIMENTALExperimental group: CA125 and HE4 assays every 4 months for 3 years to assess the ROMA score, in addition to the recommended conventional follow-up.
CA125 alone
NO INTERVENTIONControl group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 15, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
August 15, 2023
Record last verified: 2023-08