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

August 7, 2023 updated by: University Hospital, Tours

Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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).
No Intervention: CA125 alone
Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 36 months
Cost and survival data will be used to estimate the within-trial ICER.
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.
Time Frame: 36 months
QAPFY (Quality-Adjusted Progression-Free Years) will be estimated using the progression-free survival data and patient responses to the EQ-5D-5L instrument. Cost and QAPFY data will be used to estimate this within-trial ICUR.
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.
Time Frame: per year and over a 5-year period
The financial impact will be estimated from the French Health Insurance, using a budget impact model.
per year and over a 5-year period
Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
Time Frame: 36 months
Proportion of patients with a first operable recurrence, median interval between randomization and diagnosis of recurrence by imaging or biopsy
36 months
Characteristics of treatments for first recurrence (including surgery)
Time Frame: 36 months
Proportion of patients with complete surgery without macroscopic residue, without reoperation, proportion of other therapies: chemotherapy/hormone therapy/other therapies
36 months
Quality of life of women
Time Frame: 36 months
Quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-OV28 (European Organization for Research and Treatment in Cancer Quality Life Questionnaire) every 4 months for 3 years
36 months
Evolution of CA125, HE4 and ROMA score after management of the first recurrence
Time Frame: 36 months
Description of the evolution of CA125, HE4 and ROMA score after management of the first recurrence
36 months
Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.
Time Frame: 36 months
Deriving the EQ5D-5L score from responses to the EORTC QLQ-C30 and QLQ-OV28 questionnaires in women undergoing post-treatment remission follow-up of epithelial ovarian cancer.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR210313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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