Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT04363632
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1231}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality of cancer patients under active anticancer treatment', 'timeFrame': '28 days after the date of the diagnostic procedure', 'description': 'Mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '6 months (i.e. at the the time of last patient last visit)', 'description': 'Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.'}, {'measure': 'Hospitalizations', 'timeFrame': '28 days after the date of the diagnostic procedure', 'description': 'The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)'}, {'measure': 'Death', 'timeFrame': '6 months (i.e. at the the time of last patient last visit)', 'description': 'Cause of death, related or not to the COVID-19'}, {'measure': 'Complications', 'timeFrame': '28 days after the date of the diagnostic procedure', 'description': 'Associated complications described by their type'}, {'measure': 'Hospitalizations', 'timeFrame': '28 days after the date of the diagnostic procedure', 'description': 'proportion of hospitalizations'}, {'measure': "Patients' characteristics", 'timeFrame': 'At the date of the diagnostic procedure', 'description': "To describe accurately patients' characteristics in terms of demographics"}, {'measure': "Patients' characteristics", 'timeFrame': 'At the date of the diagnostic procedure', 'description': "To describe accurately patients' characteristics in type of tumor"}, {'measure': "Patients' characteristics", 'timeFrame': 'At the date of the diagnostic procedure', 'description': "To describe accurately patients' characteristics in type of anticancer treatment,"}, {'measure': "Patients' characteristics", 'timeFrame': 'At the date of the diagnostic procedure', 'description': "To describe accurately patients' characteristics in terms of comorbidities"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Oncology', 'Epidemiology', 'Predictive factors'], 'conditions': ['Sars-CoV2', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '34135471', 'type': 'DERIVED', 'citation': 'Assaad S, Zrounba P, Cropet C; ONCOVID-19 study Consortium; Blay JY. Mortality of patients with solid and haematological cancers presenting with symptoms of COVID-19 with vs without detectable SARS-COV-2: a French nationwide prospective cohort study. Br J Cancer. 2021 Aug;125(5):658-671. doi: 10.1038/s41416-021-01452-4. Epub 2021 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cancer in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nI1. Confirmed diagnosis of any type of solid or hematologic tumor;\n\nI2. Ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ;\n\nI3. Patient with suspicion of COVID-19 (clinical symptoms of COVID-19 including fever (\\>38°C) and/or respiratory tract symptoms), either confirmed or not.\n\nNote 1: Patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging. Note 2: Patients will be eligible regardless of the presence of a neutropenia (either febrile or not) ;\n\nI4. Patient and/or family did not decline data collection after complete information.'}, 'identificationModule': {'nctId': 'NCT04363632', 'acronym': 'ONCOVID-19', 'briefTitle': 'Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'ET20-069'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '73011', 'city': 'Chambéry', 'country': 'France', 'facility': 'Centre Hospitalier Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '74370', 'city': 'Metz-Tessy', 'country': 'France', 'facility': 'CH Annecy-Genevois', 'geoPoint': {'lat': 45.93343, 'lon': 6.10973}}, {'zip': '26216', 'city': 'Montélimar', 'country': 'France', 'facility': 'Groupement Hospitalier Porte de Provence', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut de Cancérologie de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon-Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '51726', 'city': 'Reims', 'country': 'France', 'facility': 'Institut Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut de cancérologie Strasbourg Europe (ICANS)', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer de Toulouse - IUCT Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Valence', 'country': 'France', 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}