Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05238467
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunological Responses of COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection rate', 'timeFrame': '05/2021-12/31/2022', 'description': 'had an antibody titer protective (1:40) at any point in testing'}], 'secondaryOutcomes': [{'measure': 'Seroconversion rate', 'timeFrame': '05/2021-12/31/2022', 'description': 'the proportion of participants who had an antibody titer fourfold increase in their antibody titer to 1:40 or greater after vaccination over baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer; Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '32250659', 'type': 'BACKGROUND', 'citation': 'Desai A, Sachdeva S, Parekh T, Desai R. COVID-19 and Cancer: Lessons From a Pooled Meta-Analysis. JCO Glob Oncol. 2020 Apr;6:557-559. doi: 10.1200/GO.20.00097. No abstract available.'}, {'pmid': '33378122', 'type': 'BACKGROUND', 'citation': 'Desai A, Gupta R, Advani S, Ouellette L, Kuderer NM, Lyman GH, Li A. Mortality in hospitalized patients with cancer and coronavirus disease 2019: A systematic review and meta-analysis of cohort studies. Cancer. 2021 May 1;127(9):1459-1468. doi: 10.1002/cncr.33386. Epub 2020 Dec 30.'}, {'pmid': '32473681', 'type': 'BACKGROUND', 'citation': 'Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G Jr, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL; COVID-19 and Cancer Consortium. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet. 2020 Jun 20;395(10241):1907-1918. doi: 10.1016/S0140-6736(20)31187-9. Epub 2020 May 28.'}, {'pmid': '33355178', 'type': 'BACKGROUND', 'citation': "Ribas A, Sengupta R, Locke T, Zaidi SK, Campbell KM, Carethers JM, Jaffee EM, Wherry EJ, Soria JC, D'Souza G; AACR COVID-19 and Cancer Task Force. Priority COVID-19 Vaccination for Patients with Cancer while Vaccine Supply Is Limited. Cancer Discov. 2021 Feb;11(2):233-236. doi: 10.1158/2159-8290.CD-20-1817. Epub 2020 Dec 19."}, {'pmid': '23051059', 'type': 'BACKGROUND', 'citation': 'Ljungman P. Vaccination of immunocompromised patients. Clin Microbiol Infect. 2012 Oct;18 Suppl 5:93-9. doi: 10.1111/j.1469-0691.2012.03971.x.'}]}, 'descriptionModule': {'briefSummary': 'Cancer patients with COVID-19 have a 30% higher mortality rate compared to the general population and are considered a high-risk group by the American Association for Cancer Research that should be given "high priority" during COVID-19 vaccine administration. Although studies have suggested that vaccination during active treatment with chemo and/or radiation therapy provides suboptimal antibody response, the studies were underpowered and heterogeneous thus putting this conclusion into question. We need data in cancer patients on immunosuppressive chemotherapy at the time of COVID vaccination to understand how immune responses compare to healthy controls and cancer patients not on immunosuppressive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group A will consist of 50 participants with a diagnosis of one of the following cancers: breast, colorectal, or prostate cancers who received myelosuppressive cytotoxic chemotherapy at the time of COVID vaccination, or who received chemotherapy within 30 days prior to the initial or booster vaccination, or who started on chemotherapy within 30 days after the initial or booster COVID vaccination. Group B will consist of 25 participants with a diagnosis of breast, colorectal, or prostate cancers who are on non-myelosuppressive treatment including endocrine therapy, tyrosine kinase inhibitor or anti-HER 2 therapy. Group C will consist of 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and \\>12 months from completion of chemotherapy or radiation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria to be eligible for enrollment:\n\n 1. Willing and able to provide written informed consent for the trial.\n 2. Male or female participants \\>18 years of age on the day of signing informed consent.\n 3. a. Participants (\\>18 years) with gastrointestinal (gastroesophageal, pancreatic, small bowel, colon, anal) solid tumors, breast, or prostate cancers who received myelosuppressive chemotherapy within 60 days prior to initial or booster COVID vaccination, or who started on chemotherapy within 60 days after the initial or booster COVID vaccination; or b. Adult participants (\\>18 years) not receiving chemotherapy at the time of initial or booster COVID vaccination, but who were on non-immunosuppressive treatments (endocrine therapy, treatment with tyrosine kinase inhibitor or antiHER-2 therapy); or c. Adult participants \\> 18 years either: (i) with no history of cancer or (ii) prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and \\>12 months from completion of chemotherapy or radiation.\n 4. a. Participants in groups A and B who have a planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine, or previous COVID vaccination within 90 days from study enrollment are eligible provided they meet all other above eligibility criteria; or b. Participants in group C who have planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine; or previous COVID vaccination within six months from study enrollment are eligible provided they meet all other above eligibility criteria\n\nExclusion Criteria:\n\n* Participants will be considered ineligible for enrollment with the following criteria:\n\n 1. Participants currently on immunotherapy\n 2. Participants with documented COVID 19 infection within \\< 6 months from study enrollment\n 3. Prior history of autoimmune disorder and are currently on immunosuppressive therapy or have received immunosuppressive therapy within the last 6-12 months prior to enrollment\n 4. No planned and no prior COVID vaccination'}, 'identificationModule': {'nctId': 'NCT05238467', 'briefTitle': 'Immunological Responses of COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Long Term Immunological Responses of COVID-19 Vaccination in Cancer Patients on Chemotherapy: a Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY20210455'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Group A will consist of 50 participants with a diagnosis of one of the following cancers: breast, colorectal, or prostate cancers who received myelosuppressive cytotoxic chemotherapy at the time of COVID vaccination, or who received chemotherapy within 30 days prior to the initial or booster vaccination, or who started on chemotherapy within 30 days after the initial or booster COVID vaccination. Cytotoxic chemotherapy can be given either in the neoadjuvant/adjuvant setting or metastatic setting.', 'interventionNames': ['Other: COVID antibody titers in the blood']}, {'label': 'B', 'description': 'Group B will consist of 25 participants with a diagnosis of breast, colorectal, or prostate cancers who are on non-myelosuppressive treatment including endocrine therapy, tyrosine kinase inhibitor or anti-HER 2 therapy.', 'interventionNames': ['Other: COVID antibody titers in the blood']}, {'label': 'C', 'description': 'Group C will consist of 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and \\>12 months from completion of chemotherapy or radiation.', 'interventionNames': ['Other: COVID antibody titers in the blood']}], 'interventions': [{'name': 'COVID antibody titers in the blood', 'type': 'OTHER', 'description': 'COVID antibody titers will be quantitatively assessed at baseline, 8 weeks and approximately 6, 9, and 12 months from date of study enrollment. Titers will be compared to levels in 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent,.and in 25 age matched cancer participants who are on non-immunosuppressive treatments as defined below.', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5047', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Alberto J. Montero', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}