Epithelial Ovarian CancerROMECONCT05991752
Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial
A study testing ROMA score evaluation in people with Epithelial Ovarian Cancer, run by University Hospital, Tours.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- ROMA score evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- ROMA score evaluation
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROMA score evaluationDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| ROMA Score | Experimental | 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. Receives: Diagnostic Test: ROMA score evaluation |
| CA125 alone | No intervention | Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Cost and survival data will be used to estimate the within-trial ICER.
Measured: 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.
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.
Measured: 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.
The financial impact will be estimated from the French Health Insurance, using a budget impact model.
Measured: per year and over a 5-year period
Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
Proportion of patients with a first operable recurrence, median interval between randomization and diagnosis of recurrence by imaging or biopsy
Measured: 36 months
Characteristics of treatments for first recurrence (including surgery)
Proportion of patients with complete surgery without macroscopic residue, without reoperation, proportion of other therapies: chemotherapy/hormone therapy/other therapies
Measured: 36 months
Quality of life of women
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
Measured: 36 months
Evolution of CA125, HE4 and ROMA score after management of the first recurrence
Description of the evolution of CA125, HE4 and ROMA score after management of the first recurrence
Measured: 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.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start31 May 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: feasibility issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991752
- Sponsor's protocol ID
- DR210313
- Acronym
- ROMECO
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé
- ClinicalTrials.gov ID
- NCT05991752
- Acronym / sponsor ID
- ROMECO / DR210313
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: feasibility issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROMA Score | Experimental | Diagnostic Test: ROMA score evaluationExperimental 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 intervention | –Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROMA score evaluationEvery 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). | Diagnostic test | ROMA Score |
Primary outcome
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.
8 secondary outcomes
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
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
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
Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
Time frame: 36 months
Characteristics of treatments for first recurrence (including surgery)
Time frame: 36 months
Quality of life of women
Time frame: 36 months
Evolution of CA125, HE4 and ROMA score after management of the first recurrence
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ROMA score evaluation in people with Epithelial Ovarian Cancer, run by University Hospital, Tours.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.