Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 7:57 PM
Study NCT ID:
NCT04771559
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': 'D000087124', 'term': 'COVID-19 Serological Testing'}], 'ancestors': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012698', 'term': 'Serologic Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study consists of two groups : 1) Cancer patients, 2) Healthy controls Blood samples will be taken from the participants of the two groups 4 weeks after the second dose of the COVID-19 vaccine and antibody testing will be performed. Additionally participants will be questioned for side effects of the vaccine and the data will be registered.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-01', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody levels', 'timeFrame': '1 month', 'description': 'COVID-19 antibody titers of the patients will be measured in blood samples.'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': '1 month', 'description': 'Participants will be questioned for common side effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer, Covid-19, Vaccine'], 'conditions': ['Covid19', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '35081732', 'type': 'DERIVED', 'citation': 'Yasin AI, Aydin SG, Sumbul B, Koral L, Simsek M, Geredeli C, Ozturk A, Perkin P, Demirtas D, Erdemoglu E, Hacibekiroglu I, Cakir E, Tanrikulu E, Coban E, Ozcelik M, Celik S, Teker F, Aksoy A, Firat ST, Tekin O, Kalkan Z, Turken O, Oven BB, Dane F, Bilici A, Isikdogan A, Seker M, Turk HM, Gumus M. Efficacy and safety profile of COVID-19 vaccine in cancer patients: a prospective, multicenter cohort study. Future Oncol. 2022 Mar;18(10):1235-1244. doi: 10.2217/fon-2021-1248. Epub 2022 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer and compare them with the healthy control group.', 'detailedDescription': 'The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer. Patients followed up in medical oncology clinic and healthy volunteers will be enrolled in the study. Blood samples of participants will be taken 4 weeks after the second dose of the COVID-19 vaccine. After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different eppendorf tubes and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples. In addition, volunteers will be questioned in terms of side effects that may develop after vaccination and the information obtained will be recorded in the database together with the clinical data of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the patient group :\n\n1. Patients with pathological and clinical cancer diagnosis\n2. Older than 18 years\n3. Patients two doses of COVID-19 vaccine administered\n4. Volunteering to participate in the study\n\nFor the control group :\n\n1. No known cancer diagnosis or history\n2. Older than 18 years\n3. Two doses of COVID-19 vaccine administered\n4. Volunteering to participate in the study -\n\nExclusion Criteria:\n\n1. Not volunteering to participate in the study\n2. \\< 18 years\n3. Not administered two doses of the COVID-19 vaccine\n4. Covid-19 infection history -'}, 'identificationModule': {'nctId': 'NCT04771559', 'briefTitle': 'Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients', 'orgStudyIdInfo': {'id': '132620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cancer patients', 'description': 'Covid-19 antibody levels of patients will be measured', 'interventionNames': ['Other: COVID-19 antibody test']}, {'type': 'OTHER', 'label': 'Healthy control', 'description': 'Covid-19 antibody levels of healthy controls will be measured', 'interventionNames': ['Other: COVID-19 antibody test']}], 'interventions': [{'name': 'COVID-19 antibody test', 'type': 'OTHER', 'description': '5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples', 'armGroupLabels': ['Cancer patients', 'Healthy control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Okmeydani Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medeniyet University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'MAHMUT GUMUS, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'MEDENIYET UNIVERSITY'}, {'name': 'AHMET BILICI, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'Medipol University'}, {'name': 'HACI MEHMET TURK, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'BEZMIALEM UNIVERSITY'}, {'name': 'MESUT SEKER, PROF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BEZMIALEM UNIVERSITY'}, {'name': 'AYSE IREM YASIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BEZMIALEM UNIVERSITY'}, {'name': 'BILGE SUMBUL, ASOC.PROF.', 'role': 'STUDY_CHAIR', 'affiliation': 'BEZMIALEM UNIVERSITY'}, {'name': 'FAYSAL DANE, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'Acibadem University'}, {'name': 'CAGLAYAN GEREDELI, ASOC.PROF.', 'role': 'STUDY_CHAIR', 'affiliation': 'OKMEYDANI RESEARCH HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ayşe İrem Yasin', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}