Status:
COMPLETED
Immunological Responses of COVID-19 Vaccination
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Cancer; Chemotherapy
Eligibility:
All Genders
18+ years
Brief Summary
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 gi...
Eligibility Criteria
Inclusion
- Participants must meet all of the following inclusion criteria to be eligible for enrollment:
- Willing and able to provide written informed consent for the trial.
- Male or female participants \>18 years of age on the day of signing informed consent.
- 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.
- 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
Exclusion
- Participants will be considered ineligible for enrollment with the following criteria:
- Participants currently on immunotherapy
- Participants with documented COVID 19 infection within \< 6 months from study enrollment
- 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
- No planned and no prior COVID vaccination
Key Trial Info
Start Date :
May 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05238467
Start Date
May 21 2021
End Date
February 13 2023
Last Update
February 21 2023
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-5047