Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 12:10 AM
Study NCT ID:
NCT04386512
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '2 months'}, {'measure': 'transfer to ICU', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid', 'lymphoma', 'epidemiology'], 'conditions': ['COVID', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).\n\nThe specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.\n\nTranslated with www.DeepL.com/Translator (free version)', 'detailedDescription': 'I\n\nMethods :\n\n* Multicentric retrospective observational epidemiological study based on the collection of data from patient records.\n* Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase.\n* Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI.\n* Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers.\n* Estimated total number of sites: 10-15 and number of cases to be collected: 50-60.\n\nTranslated with www.DeepL.com/Translator (free version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a current or past history of lymphoma who were hospitalized with Covid-19 infection between March the 1st and April the 30th in ile de France or Est region in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization.\n* In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients.\n\nExclusion Criteria:\n\nPatients who refused to participate\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04386512', 'acronym': 'LymphoCov1', 'briefTitle': 'Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'officialTitle': 'Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique', 'orgStudyIdInfo': {'id': 'P20/12_LymphoCov'}}, 'contactsLocationsModule': {'locations': [{'city': 'Le Chesnay', 'country': 'France', 'facility': 'CH de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'investigator MD', 'investigatorFullName': 'Caroline BESSON', 'investigatorAffiliation': 'Versailles Hospital'}}}}