Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04865133
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety 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'}], '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': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence and severity of COVID-19 infection after the vaccination in cancer patients and health individuals', 'timeFrame': 'Up to 12 months', 'description': 'Will use descriptive statistics (mean, median, range for continuous variables and frequency/percentage for categorical variables) to analyze demographic data including age, ethnicity, and comorbidity in healthy individuals and cancer patients as well as cancer type and current cancer treatment in cancer patients in association with incidence as well as severity of subsequent COVID-19 infection after the vaccination.'}], 'primaryOutcomes': [{'measure': 'Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals', 'timeFrame': 'Up to 12 months', 'description': 'Wilcoxon rank sum test will be used to compare between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).'}], 'secondaryOutcomes': [{'measure': 'Adverse events of COVID-19 vaccines in cancer patients and health individuals', 'timeFrame': 'Up to 12 months', 'description': 'Will use descriptive statistics (mean, median, range for continuous variables and frequency/percentage for categorical variables) to analyze demographic data including age, ethnicity, and comorbidity in healthy individuals and cancer patients as well as cancer type and current cancer treatment in cancer patients in association with adverse events after the vaccination.'}, {'measure': 'T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.\n\nOUTLINE:\n\nPatients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with cancer on or will be starting on systemic cytotoxic chemotherapy for their cancer and healthy individuals who will receive COVID-19 vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)\n* Willing and able to provide research blood samples\n* Capable of providing valid informed consent\n* For cancer patient cohort:\n\n * Male or female age \\>= 18 years\n * Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy\n* For healthy individual cohort:\n\n * Male or female age \\>= 18 years\n * No history of active malignancy =\\< 3 years\n* EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix\n* NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =\\< 3 years\n* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples\n* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent\n* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age \\>= 18 years\n* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody\n\nExclusion Criteria:\n\n* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator'}, 'identificationModule': {'nctId': 'NCT04865133', 'briefTitle': 'Efficacy and Safety of COVID-19 Vaccine in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Efficacy and Safety of COVID-19 Vaccine in Cancer Patients', 'orgStudyIdInfo': {'id': '21-001818'}, 'secondaryIdInfos': [{'id': 'NCI-2021-03137', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (biospecimen collection, medical record)', 'description': 'Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Electronic Health Record Review']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Observational (biospecimen collection, medical record)']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Medical record reviewed', 'armGroupLabels': ['Observational (biospecimen collection, medical record)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Saranya Chumsri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}