Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 5:44 PM
Study NCT ID:
NCT04776005
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D016609', 'term': 'Neoplasms, Second Primary'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-30', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 vaccine response at 12 months', 'timeFrame': '12 months', 'description': 'IgG anti-Sarc-CoV-2 S-protein titer at 12 months'}], 'secondaryOutcomes': [{'measure': 'Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination', 'timeFrame': 'Day 0', 'description': 'Rate of patients presenting the anti Sarc-CoV-2 S-protein antibodies before vaccination in the study population.'}, {'measure': 'Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination', 'timeFrame': 'Day 0', 'description': 'Rate of patients presenting the anti Sarc-CoV-2 N-protein antibodies before vaccination in the study population.'}, {'measure': 'SARS-CoV-2 vaccine response after first dose of vaccine', 'timeFrame': 'Day 24 +/- 4 days', 'description': 'IgG anti-Sarc-CoV-2 S-protein titer after the first injection of vaccine'}, {'measure': 'SARS-CoV-2 vaccine response at 3 months', 'timeFrame': '3 months', 'description': 'IgG anti-Sarc-CoV-2 S-protein titer at 3 months'}, {'measure': 'SARS-CoV-2 vaccine response at 6 months', 'timeFrame': '6 months', 'description': 'IgG anti-Sarc-CoV-2 S-protein titer at 6 months'}, {'measure': 'SARS-CoV-2 vaccine safety in the study population', 'timeFrame': '12 months', 'description': 'Occurence of the adverse events related to the SARS-CoV-2 vaccine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malignant pathology', 'Hematologic malignancy', 'COVID-19', 'Vaccine', 'Sars-CoV-2 antibody'], 'conditions': ['Solid Tumor', 'Hematologic Malignancy', 'Thoracic Cancer', 'Cancer, Treatment-Related', 'Vaccine Response Impaired']}, 'descriptionModule': {'briefSummary': 'In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used.\n\nThere are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment.\n\nThis multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.', 'detailedDescription': 'During the visit carried out as part of the follow-up, participation in this study will be proposed to any patient who is treated for a malignant disease (solid or hematological tumors) within the university hospitals of AP-HP.Nord.\n\nThe patients participating in this prospective cohort will benefit from all standard care his/her condition requires.\n\nClinical and biological data will be collected as part of the usual follow-up. Clinical data: pathology, stage, treatment line, type of current treatment and date of the last treatment administered, previous treatments, radiotherapy, concept of radiation lung disease, history of pneumonectomy, comorbidities, performance status, history of coronavirus disease 2019 (COVID-19).\n\nLaboratory data: pre-vaccination polynuclear neutrophil count, lymphocyte counts, plasma protein electrophoresis or Ig weight dosage (routine care in hematology), lactate dehydrogenase (LDH), C-reactive protein (CRP), albuminemia in the previous month.\n\nVaccination data: type of vaccine, date of the 1st injection, date of the 2nd injection, pre-vaccination antibody levels\n\n* Seroconversion with anti-S IgG after anti-Sars-CoV-2 vaccination\n* Anti-S and / or anti-N Sars-CoV-2 IgG seroprevalence before vaccination\n* Adverse effects related to vaccines\n* Levels of the anti-S IgG antibodies in AU / ml\n\nDuring visits between D21 and D28 (before the 2nd injection), at month 3, month 6 and month 12, the following data will be collected:\n\n* Antibody levels\n* Adverse effects related to vaccines\n* Levels of the anti-S IgG antibodies in AU / ml\n* Associated side effects\n* Occurrence of COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are treated for a malignant disease (solid or hematological tumors) within the CHU AP-HP.Nord and who are willing to get a SARS-CoV-2 vaccination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with malignant disease undergoing treatment at Saint Louis Hospital or Bichat Hospital (for chest cancer)\n* with chemotherapy\n* with chemotherapy + Immunotherapy\n* with immunotherapy\n* with targeted therapies\n* with radiotherapy\n* in the event of radiation pneumonitis after radiotherapy for lung cancers\n* after pneumonectomy for lung cancer\n* Patient informed and having expressed their non-opposition to participating in this research\n\nExclusion Criteria:\n\n* Patient with a contraindication to Sars-Cov2 vaccination'}, 'identificationModule': {'nctId': 'NCT04776005', 'acronym': 'COVIDVAC OH', 'briefTitle': 'COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord', 'orgStudyIdInfo': {'id': 'APHP210640'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with malignant disease undergoing chemotherapy', 'description': 'Patients with malignant disease undergoing chemotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.', 'interventionNames': ['Other: Data collection']}, {'label': 'Patients with malignant disease undergoing chemotherapy + immunotherapy', 'description': 'Patients with malignant disease undergoing chemotherapy + immunotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.', 'interventionNames': ['Other: Data collection']}, {'label': 'Patients with malignant disease undergoing immunotherapy', 'description': 'Patients with malignant disease undergoing immunotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.', 'interventionNames': ['Other: Data collection']}, {'label': 'Patients with malignant disease treated with targeted therapies', 'description': 'Patients with malignant disease treated with targeted therapies within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.', 'interventionNames': ['Other: Data collection']}, {'label': 'Patients with malignant disease undergoing radiotherapy', 'description': 'Patients with malignant disease undergoing radiotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.', 'armGroupLabels': ['Patients with malignant disease treated with targeted therapies', 'Patients with malignant disease undergoing chemotherapy', 'Patients with malignant disease undergoing chemotherapy + immunotherapy', 'Patients with malignant disease undergoing immunotherapy', 'Patients with malignant disease undergoing radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luis TEIXEIRA, MD, PhD', 'role': 'CONTACT', 'email': 'luis.teixeira@aphp.fr', 'phone': '+33 142499613'}], 'facility': 'Saint-Louis Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gérard ZALCMAN, MD, PhD', 'role': 'CONTACT', 'email': 'gerard.zalcman@aphp.fr'}], 'facility': 'Bichat Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Luis TEIXEIRA, MD, PhD', 'role': 'CONTACT', 'email': 'luis.teixeira@aphp.fr', 'phone': '+33 142499613'}], 'overallOfficials': [{'name': 'Luis TEIXEIRA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}