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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03750994
Other study ID # RuBIH2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2018
Est. completion date October 2020

Study information

Verified date November 2018
Source Assistance Publique - Hôpitaux de Paris
Contact Claude Preudhomme, Professor
Phone + 33 3 20 44 47 82
Email claude.preudhomme@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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:

1. Myelodysplasia (MDS)

2. Acute lymphocytic leukemia (T) (ALL)

3. Lymphoproliferative disorders (LPD)

4. Acute myeloblastic leukemia (AML)

5. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3960
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with haematological malignancies referred for molecular diagnosis workup. RuBIH2 will focus on 5 clinical situations in onco-haematology:

1. Myelodysplasia (MDS)

2. Acute lymphocytic leukemia (T) (ALL)

3. Lymphoproliferative disorders (LPD)

4. Acute myeloblastic leukemia (AML)

5. Myeloproliferative disorders (MPD)

Exclusion Criteria:

- Other haematological diseases not included in the list above.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Angers Angers
France Hôpital Avicenne AP-HP Bobigny
France CHU de Bordeaux Bordeaux
France CHRU Brest Brest
France CHU Estaing Clermont Ferrand
France Hôpital Henri Mondor AP-HP Créteil
France CHRU Dijon Bourgogne Dijon
France Centre hospitalier régional universitaire de Lille Lille Hauts De France
France CHU Limoges Limoges
France CHU Lyon Sud Pierre Bénite Lyon
France CHU Montpellier Montpellier
France CHU Hôtel Dieu Nantes
France CHU Nice Nice
France Hôpital Cochin AP-HP Paris
France Hôpital Necker AP-HP Paris
France Hôpital Pitié-Salpêtrière AP-HP Paris
France Hôpital Robert Debré Paris
France Hôpital Saint Antoine AP-HP Paris
France Hôpital St Louis AP-HP Paris
France CHU Robert Debré Reims Reims
France CHU Pontchaillou Rennes
France Centre Henri-Becquerel Rouen
France Centre hospitalier universitaire de Saint-Étienne Saint-Étienne
France Hôpitaux Universitaires Strasbourg Strasbourg
France CHU Toulouse Toulouse
France Institut Gustave Roussy Villejuif

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies. 2 years
Primary Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres. 2 years
Primary Average time in days between the Next Generation Sequencing (NGS) prescription being issued and the results being rendered to the clinician. 2 years
Primary Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response 2 years
Primary Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient. 2 years
Primary Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment. 2 years
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