Economic Evaluation of Innovative Molecular Analyses in Onco-haematology
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|ClinicalTrials.gov Identifier: NCT03750994|
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : November 23, 2018
|Condition or disease|
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.
WP2 will update existing prescription guidelines based on evidence from the literature and evidence from the WP3. These prescription guidelines will in turn be valued and provide recommendations for a flat fee bundle for pre-specified clinical situations.
WP3 will provide evidence on the clinical impact of molecular diagnosis (in particular NGS) in the 5 pre-specified conditions. Changes in patient management will be measured using a prospective questionnaire for an estimated 3960 molecular tests. The impact of the test on the patient clinical pathway will be analysed. The impact of molecular tests on patient outcome will not be measured.
WP4 will use information from WP1 and WP2 to estimate the budget impact and to provide scenario analyses on the territorial organisation of molecular biology platforms. Based on the estimation of the national activity of molecular onco-haematology platforms the annual functioning budget required to implement molecular diagnosis in France will be estimated.
|Study Type :||Observational|
|Estimated Enrollment :||3960 participants|
|Official Title:||Economic Evaluation of Innovative Molecular Analyses in Onco-haematology (PRME-K 2016)|
|Actual Study Start Date :||October 18, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
- Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies. [ Time Frame: 2 years ]
- Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres. [ Time Frame: 2 years ]
- Average time in days between the Next Generation Sequencing (NGS) prescription being issued and the results being rendered to the clinician. [ Time Frame: 2 years ]
- Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response [ Time Frame: 2 years ]
- Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient. [ Time Frame: 2 years ]
- Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750994
|Contact: Claude Preudhomme, Professor||+ 33 3 20 44 47 email@example.com|
|Contact: Elisabeth Macintyre, Professor||+ 33 1 44 49 49 firstname.lastname@example.org|
|Principal Investigator:||Claude Preudhomme, Professor||DRCI AP-HP|