Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-28 @ 11:10 PM
Study NCT ID:
NCT04910295
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titre after vaccination', 'timeFrame': '21-28 days after completion of vaccination', 'description': 'Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)'}], 'secondaryOutcomes': [{'measure': 'Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics', 'timeFrame': '21-28 days after completion of vaccination', 'description': 'Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)'}, {'measure': 'Incidence of COVID-19 infection', 'timeFrame': '6 months after completion of vaccination', 'description': 'Incidence of actual COVID-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Covid19']}, 'descriptionModule': {'briefSummary': 'Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cancer who are receiving or received anti-cancer drugs at Seoul National University Hospital, Seoul, Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years of age or older\n* Patients who are receiving or received anti-cancer drugs\n* Those who are not vaccinated against COVID-19 at the time of enrollment\n* Written informed consent\n\nExclusion Criteria:\n\n* Any contraindications to COVID-19 vaccines\n* Those who were already vaccinated\n* Those who are on immunosuppressants or infected with HIV\n* Those who underwent organ transplantation\n* Active infections (for example, pneumonia)'}, 'identificationModule': {'nctId': 'NCT04910295', 'briefTitle': 'Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients', 'orgStudyIdInfo': {'id': 'H-2013-121-1206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COVID-19 vaccine', 'type': 'DRUG', 'description': 'Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing of IPD will be discussed and decided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kyung-Hun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}