Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-19 @ 11:51 AM
Study NCT ID:
NCT05963061
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Myeloid Leukemia (CML) Real-Life Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2034-04-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and biological data collection', 'timeFrame': 'Until death or last follow up (up to 30 years)', 'description': "Aims of the registry are the collection of clinical data to gain further insights about patients's CML treated with ITK's (treatment, prognosis, therapeutical response)."}], 'secondaryOutcomes': [{'measure': 'Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)', 'timeFrame': 'At diagnosis'}, {'measure': 'BMI with evaluation of weight and height', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of major molecular response (MMR) with transcript BCR::ABL in %', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of molecular response MR4 with transcript BCR::ABL in %', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of molecular response MR4.5 with transcript BCR::ABL in %', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of molecular response MR5 with transcript BCR::ABL in %', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of cytogenetic response', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of TKI efficacy based on transcript BCR::ABL in %', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Evaluation of TKI tolerance (adverses events)', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': 'Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response', 'timeFrame': 'Until death or last follow up (up to 30 years)'}, {'measure': "Listing of major medical history of patient's CML", 'timeFrame': 'Until death or last follow up (up to 30 years)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukemia', 'Leukemia, Myeloid', 'Chronic myeloid leukemia', 'Chronic, BCR::ABL Positive', 'Hematologic Malignancies', 'Tyrosine kinase inhibitor (TKI)', 'Targeted therapy'], 'conditions': ['Chronic Myeloid Leukemia (CML)']}, 'referencesModule': {'references': [{'pmid': '36040480', 'type': 'RESULT', 'citation': 'Saugues S, Lambert C, Daguenet E, Ansah HJ, Turhan A, Huguet F, Guerci-Bresler A, Tchirkov A, Hamroun D, Hermet E, Pereira B, Berger MG. Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukemia: data from the French observatory. Ann Hematol. 2022 Oct;101(10):2241-2255. doi: 10.1007/s00277-022-04955-z. Epub 2022 Aug 30.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s00277-022-04955-z', 'label': 'Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukaemia: Data from the French observatory'}]}, 'descriptionModule': {'briefSummary': 'Establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of CML patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.', 'detailedDescription': 'Observational study collecting real-life clinico-biological data from patients with CML. Data are collected prospectively and retrospectively, from diagnosis and throughout the long-term follow-up of CML (follow up continues after treatment stopped).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with a diagnose of CML', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed for chronic myelocytic leukemia\n\nExclusion Criteria:\n\n* CML allograft without TKI treatment\n* Refusal or inability to sign the consent'}, 'identificationModule': {'nctId': 'NCT05963061', 'briefTitle': 'Chronic Myeloid Leukemia (CML) Real-Life Database', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Chronic Myeloid Leukemia (CML) Real-Life Database', 'orgStudyIdInfo': {'id': 'CML Observatory'}}, 'contactsLocationsModule': {'locations': [{'city': 'Annecy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Parry, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Atchroue Johnson Ansah, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital, Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clemront-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Le Puy-en-Velay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vanessa Pante, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Emile Roux', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amelie Penot, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital, Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aude CHARBONNIER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agnès Guerci-Bresler, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospital, Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ali Turhan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bicetre Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence Legros, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hopital Paul Brousse', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Martine Escoffre-Barbe, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rochefort', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume DENIS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Rochefort', 'geoPoint': {'lat': 45.94304, 'lon': -0.96774}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Denis Guyotat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Françoise Huguet, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital, Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Versailles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Rousselot, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Versailles Hospital', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Marc BERGER, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, {'name': 'Bicetre Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, {'name': 'CH Annecy Genevois', 'class': 'OTHER'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'Hopital Paul Brousse', 'class': 'OTHER'}, {'name': 'Versailles Hospital', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Emile Roux', 'class': 'OTHER'}, {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de Rochefort', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}