Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT03750994
Status:
UNKNOWN
Last Update Posted:
2018-11-23
First Post:
2017-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Evaluation of Innovative Molecular Analyses in Onco-haematology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3960}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies.', 'timeFrame': '2 years'}, {'measure': 'Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres.', 'timeFrame': '2 years'}, {'measure': 'Average time in days between the Next Generation Sequencing (NGS) prescription being issued and the results being rendered to the clinician.', 'timeFrame': '2 years'}, {'measure': 'Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response', 'timeFrame': '2 years'}, {'measure': 'Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient.', 'timeFrame': '2 years'}, {'measure': 'Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment.', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haematological Malignancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe PRME RuBIH2 will focus on 5 clinical situations in onco-haematology:\n\n1. Myelodysplasia (MDS)\n2. Acute lymphocytic leukemia (T) (ALL)\n3. Lymphoproliferative disorders (LPD)\n4. Acute myeloblastic leukemia (AML)\n5. Myeloproliferative disorders (MPD)\n\nThe project is organised in 4 complementary work packages (WP): WP1 Cost evaluation, WP2 Prescription Guidelines, WP3 Clinical Validation and WP4 Budget Impact and Organisation.\n\nWP1 will provide costing information on molecular tests and will build on previous studies conducted in France.\n\nWP2 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.\n\nWP3 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.\n\nWP4 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for molecular diagnosis at one of the certified molecular onco-haematology platforms in France.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with haematological malignancies referred for molecular diagnosis workup. RuBIH2 will focus on 5 clinical situations in onco-haematology:\n\n 1. Myelodysplasia (MDS)\n 2. Acute lymphocytic leukemia (T) (ALL)\n 3. Lymphoproliferative disorders (LPD)\n 4. Acute myeloblastic leukemia (AML)\n 5. Myeloproliferative disorders (MPD)\n\nExclusion Criteria:\n\n* Other haematological diseases not included in the list above.'}, 'identificationModule': {'nctId': 'NCT03750994', 'briefTitle': 'Economic Evaluation of Innovative Molecular Analyses in Onco-haematology', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Economic Evaluation of Innovative Molecular Analyses in Onco-haematology (PRME-K 2016)', 'orgStudyIdInfo': {'id': 'RuBIH2'}}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Claude PREUDHOMME', 'role': 'CONTACT', 'email': 'Claude.PREUDHOMME@chru-lille.fr'}], 'facility': 'Centre hospitalier régional universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Odile Blanchet', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Fanny Baran-Marszak', 'role': 'CONTACT'}], 'facility': 'Hôpital Avicenne AP-HP', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Audrey Bidet', 'role': 'CONTACT'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Eric Lippert', 'role': 'CONTACT'}], 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Marc Berger', 'role': 'CONTACT'}], 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Dominique Bories', 'role': 'CONTACT'}], 'facility': 'Hôpital Henri Mondor AP-HP', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Mary Callanan', 'role': 'CONTACT'}], 'facility': 'CHRU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr David Rizzo', 'role': 'CONTACT'}], 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Pierre Sujobert', 'role': 'CONTACT'}], 'facility': 'CHU Lyon Sud Pierre Bénite', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Melissa Alamé', 'role': 'CONTACT'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Yannick LE BRIS', 'role': 'CONTACT'}], 'facility': 'CHU Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Sophie Raynaud', 'role': 'CONTACT'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Frédéric Davi', 'role': 'CONTACT'}], 'facility': 'Hôpital Pitié-Salpêtrière AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Hélène Cave', 'role': 'CONTACT'}], 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Jean-Michel Cayuela', 'role': 'CONTACT'}], 'facility': 'Hôpital St Louis AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Olivier Kosmider', 'role': 'CONTACT'}], 'facility': 'Hôpital Cochin AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Elizabeth Macintyre', 'role': 'CONTACT', 'email': 'elizabeth.macintyre@aphp.fr'}], 'facility': 'Hôpital Necker AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor François Delhommeau', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint Antoine AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Pascale Cornillet-Lefebvre', 'role': 'CONTACT'}], 'facility': 'CHU Robert Debré Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Thierry Fest', 'role': 'CONTACT'}], 'facility': 'CHU Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Martine Becker', 'role': 'CONTACT'}], 'facility': 'Centre Henri-Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Pascale Flandrin Gresta', 'role': 'CONTACT'}], 'facility': 'Centre hospitalier universitaire de Saint-Étienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Laurent Miguet', 'role': 'CONTACT'}], 'facility': 'Hôpitaux Universitaires Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Professor Eric Delabesse', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Christophe Marzac', 'role': 'CONTACT'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Claude Preudhomme, Professor', 'role': 'CONTACT', 'email': 'claude.preudhomme@chru-lille.fr', 'phone': '+ 33 3 20 44 47 82'}, {'name': 'Elisabeth Macintyre, Professor', 'role': 'CONTACT', 'email': 'elizabeth.macintyre@aphp.fr', 'phone': '+ 33 1 44 49 49 47'}], 'overallOfficials': [{'name': 'Claude Preudhomme, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRCI AP-HP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}