Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 320
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ROMA score evaluation (Diagnostic Test)
CA125 alone
Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.(36 months)
- 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)
- 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)
- Evolution of CA125, HE4 and ROMA score after management of the first recurrence(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)
- Characteristics of treatments for first recurrence (including surgery)(36 months)
- Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)(36 months)
- Quality of life of women(36 months)