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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CA125 alone | No Intervention | Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROMA score evaluation | Diagnostic 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). |
| 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. | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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. | 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) | 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) | 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 | 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 | 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. | 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 |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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