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Trial record 48 of 1318 for:    Hematologic neoplasm

Economic Evaluation of Innovative Molecular Analyses in Onco-haematology

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ClinicalTrials.gov Identifier: NCT03750994
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease
Haematological Malignancy

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 3960 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies. [ Time Frame: 2 years ]
  2. Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres. [ Time Frame: 2 years ]
  3. 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 ]
  4. Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response [ Time Frame: 2 years ]
  5. Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient. [ Time Frame: 2 years ]
  6. Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment. [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for molecular diagnosis at one of the certified molecular onco-haematology platforms in France.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Claude Preudhomme, Professor + 33 3 20 44 47 82 claude.preudhomme@chru-lille.fr
Contact: Elisabeth Macintyre, Professor + 33 1 44 49 49 47 elizabeth.macintyre@aphp.fr

Locations
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France
Centre hospitalier régional universitaire de Lille Recruiting
Lille, Hauts De France, France, 59000
Contact: Professor Claude PREUDHOMME       Claude.PREUDHOMME@chru-lille.fr   
CHU Angers Recruiting
Angers, France
Contact: Dr Odile Blanchet         
Hôpital Avicenne AP-HP Recruiting
Bobigny, France
Contact: Professor Fanny Baran-Marszak         
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Dr Audrey Bidet         
CHRU Brest Recruiting
Brest, France
Contact: Dr Eric Lippert         
CHU Estaing Recruiting
Clermont Ferrand, France
Contact: Professor Marc Berger         
Hôpital Henri Mondor AP-HP Recruiting
Créteil, France
Contact: Dr Dominique Bories         
CHRU Dijon Bourgogne Recruiting
Dijon, France
Contact: Professor Mary Callanan         
CHU Limoges Recruiting
Limoges, France
Contact: Dr David Rizzo         
CHU Lyon Sud Pierre Bénite Recruiting
Lyon, France
Contact: Dr Pierre Sujobert         
CHU Montpellier Recruiting
Montpellier, France
Contact: Dr Melissa Alamé         
CHU Hôtel Dieu Recruiting
Nantes, France
Contact: Dr Yannick LE BRIS         
CHU Nice Recruiting
Nice, France
Contact: Professor Sophie Raynaud         
Hôpital Pitié-Salpêtrière AP-HP Recruiting
Paris, France, 75004
Contact: Professor Frédéric Davi         
Hôpital Robert Debré Recruiting
Paris, France, 75004
Contact: Professor Hélène Cave         
Hôpital St Louis AP-HP Recruiting
Paris, France, 75004
Contact: Dr Jean-Michel Cayuela         
Hôpital Cochin AP-HP Recruiting
Paris, France
Contact: Professor Olivier Kosmider         
Hôpital Necker AP-HP Recruiting
Paris, France
Contact: Professor Elizabeth Macintyre       elizabeth.macintyre@aphp.fr   
Hôpital Saint Antoine AP-HP Recruiting
Paris, France
Contact: Professor François Delhommeau         
CHU Robert Debré Reims Recruiting
Reims, France
Contact: Dr Pascale Cornillet-Lefebvre         
CHU Pontchaillou Recruiting
Rennes, France
Contact: Professor Thierry Fest         
Centre Henri-Becquerel Recruiting
Rouen, France
Contact: Dr Martine Becker         
Centre hospitalier universitaire de Saint-Étienne Recruiting
Saint-Étienne, France
Contact: Dr Pascale Flandrin Gresta         
Hôpitaux Universitaires Strasbourg Recruiting
Strasbourg, France
Contact: Dr Laurent Miguet         
CHU Toulouse Recruiting
Toulouse, France
Contact: Professor Eric Delabesse         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Dr Christophe Marzac         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Claude Preudhomme, Professor DRCI AP-HP

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03750994     History of Changes
Other Study ID Numbers: RuBIH2
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases