Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT04865133
Eligibility Criteria:
Inclusion Criteria:
* 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)
* Willing and able to provide research blood samples
* Capable of providing valid informed consent
* For cancer patient cohort:
* Male or female age \>= 18 years
* Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
* For healthy individual cohort:
* Male or female age \>= 18 years
* No history of active malignancy =\< 3 years
* EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
* NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =\< 3 years
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age \>= 18 years
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04865133
Study Brief:
Protocol Section:
NCT04865133