Economic Evaluation of Innovative Molecular Analyses in Onco-haematology (PRME-K 2016)
试验速览
- 阶段
- 不适用
- 入组人数
- 3,960
- 试验地点
- 26
- 主要终点
- Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies.
研究概览
简要总结
To evaluate the impact of innovative molecular diagnostics on the clinical management of patients with haematological malignancies via updated Appropriate-Prescribing-Guides including Next-Generation Sequencing (NGS) panels, facilitated therapeutic orientation, and optimised use of costly novel therapeutics and risk-adapted treatment. A micro-costing approach will be used to develop flat fee tarifs for NGS analyses.
详细描述
The 12 somatic genetic cancer tests that have received temporary authorisation in France form the basis of this study. These tests are not yet in the national biology reimbursement nomenclature but are supported by the ministry of health in a temporary list "Le référentiel des actes innovants hors nomenclature de biologie et d'anatomocytopathologie" (RIHN).
The PRME RuBIH2 will focus on 5 clinical situations in onco-haematology:
- Myelodysplasia (MDS)
- Acute lymphocytic leukemia (T) (ALL)
- Lymphoproliferative disorders (LPD)
- Acute myeloblastic leukemia (AML)
- Myeloproliferative disorders (MPD)
The project is organised in 4 complementary work packages (WP): WP1 Cost evaluation, WP2 Prescription Guidelines, WP3 Clinical Validation and WP4 Budget Impact and Organisation.
WP1 will provide costing information on molecular tests and will build on previous studies conducted in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with haematological malignancies referred for molecular diagnosis workup. RuBIH2 will focus on 5 clinical situations in onco-haematology:
- •Myelodysplasia (MDS)
- •Acute lymphocytic leukemia (T) (ALL)
- •Lymphoproliferative disorders (LPD)
- •Acute myeloblastic leukemia (AML)
- •Myeloproliferative disorders (MPD)
排除标准
- •Other haematological diseases not included in the list above.
结局指标
主要结局
Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies.
时间窗: 2 years
Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres.
时间窗: 2 years
Average time in days between the Next Generation Sequencing (NGS) prescription being issued and the results being rendered to the clinician.
时间窗: 2 years
Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response
时间窗: 2 years
Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient.
时间窗: 2 years
Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment.
时间窗: 2 years
次要结局
未报告次要终点