Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04452604
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical prognostic factors for infection with COVID-19', 'timeFrame': 'Day 0', 'description': 'Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)'}, {'measure': 'Biological prognostic factors for infection with COVID-19', 'timeFrame': 'Day 0', 'description': 'neutrophils and lymphocytes count at the time of SARS-COV2 infection'}, {'measure': 'Medical care of Coronavirus infection', 'timeFrame': 'within 12 months after diagnosis', 'description': 'Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloblastic Leukemia', 'Acute Lymphoblastic Leukemia', 'SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia.\n\nThe main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 infected patients with AML or ALL', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years\n* Diagnosis of a proven or probable SARS-CoV-2 infection according to the following criteria:\n\n 1. Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted)\n 2. Probable infection: negative PCR but association of\n\n 1. Evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite AND\n 2. evocative radiological signs, on CT: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral AND\n 3. absence of differential diagnosis\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04452604', 'acronym': 'COVLA', 'briefTitle': 'Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)', 'orgStudyIdInfo': {'id': 'COVLA'}}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Chu Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU ANGERS - Maladies du sang', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Ch Avignon', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la Côte Basque - Hématologie', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen - IHBN - Hématologie Clinique', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'city': 'Dunkirk', 'country': 'France', 'facility': 'Centre Hospitalier de Dunkerque', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hopital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Saint Vicent de Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Chu Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes - Hématologie 2', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'HOPITAL SAINT ELOI - Hematologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'facility': 'HOPITAL E. MULLER - Hématologie', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU HOTEL DIEU - Hématologie Clinique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': 'CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Bordeaux Pessac', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims - Hôpital Robert Debré - Hématologie Clinique', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Pontchaillou - Hématologie', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Pierre', 'country': 'France', 'facility': 'Chu de La Reunion - Site Sud', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': "Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Versailles', 'country': 'France', 'facility': 'Centre Hospitalier de Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Pierre-Yves DUMAS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acute Leukemia French Association', 'class': 'OTHER'}, {'name': 'Group for Research in Adult Acute Lymphoblastic Leukemia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}