Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2021-02-24
2022-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective - Cancer Patients that have received COVID-19 Vaccination
COVID-19 Vaccine
COVID-19 Vaccine
Interventions
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COVID-19 Vaccine
COVID-19 Vaccine
Eligibility Criteria
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Inclusion Criteria
2. Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
3. Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
4. Able to provide informed consent
5. Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.
Exclusion Criteria
2. Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
3. Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:
* Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
* Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\])
* Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
4. Pregnant or breastfeeding
5. Unable to comply with study related procedures as determined by the study team.
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Kate Lathrop
Clinical Investigator
Principal Investigators
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Dimpy Shah, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio
Locations
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Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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CTMS 21-0012
Identifier Type: -
Identifier Source: org_study_id
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