Bladder Cancer Clinical Trial
Impact of COVID-19 on GU Disease
Summary
The purpose of this research study is to identify patients with GU disease with active or past COVID-19 infection.
Participants will be asked to:
Complete an Online COVID-19 Questionnaire.
Disclose if the patient has or had Genitourinary cancer or benign urologic condition
Provide urine specimen for research
Provide 4 tablespoons of blood for testing blood for research.
Provide permission to access medical records, such as patient lab results, medical history, imaging reports, etc.
Full Description
COVID-19 has a higher incidence in males compared to females and cancer patients have a higher risk of contracting COVID-19, and developing complications, and deteriorate more rapidly. COVID19 pandemic poses significant challenges in clinical decision-making, which has impacted management of GU patients. In order to mitigate the risk associated with COVID19 pandemic while also providing the best clinical care for patients a screening approach is essential. Clinicians taking care of cancer patients will be expected not only to understand impact of COVID19 but also incorporate a triage tool to decide which patients need immediate treatment. This prospective study presented in this IRB is about establishing a screening tool for GU patients with pre-existing cancer or with benign urological disease (e.g. BPH, kidney stone, bladder infection, urinary tract infections etc) and for those who are dealing with decisions for biopsy, active surveillance, surgery, radiation, hormonal and chemotherapy.
The study team is expecting to enroll 15240 subjects under this study.
Procedures involved in the study:
Consenting patients for the study.
Screening/Baseline REDCap survey to determine their COVID-19 symptoms.
Blood sample collection: This will be obtained for research studies including immune monitoring assays
Urine sample collection for bio-marker analysis.
Data collection from medical records, such as:
Clinical diagnoses, including date of confirmation of SARS-CoV-2 infection
Any pertinent medical history, including concomitant medications, and comorbidities that pre- date enrollment in the study, or that occur during enrollment in the study
Laboratory values from time of blood procurement
All imaging (X-ray, MRI, CAT, PAT, PSMA, Ultrasound, and Pathology etc.) performed from time of initial diagnosis until death, and any needed imaging that pre- date enrollment that may serve as a comparative to pre/post treatment imaging.
Collection time of samples in relation to study treatment
Demographic data
REDCap questionnaire, COVID-19 symptoms and severity of the symptoms
Eligibility Criteria
Inclusion Criteria:
Subjects must be men and women 40 years of age or older
Subjects at risk or with GU cancer (Prostate, Bladder, Kidney)
Subjects with benign GU disorders ( BPH, UTI, Bladder infection and kidney stone)
Subjects must have a GU disease that requires clinic visit as determined by physician or healthcare provider following a telehealth appointment
Willing and able to provide blood and urine samples
Willing and able to complete a questionnaire to determine the COVID-19 symptoms.
Willing and able to sign informed consent form
Exclusion Criteria:
Men and women below 40 years of age
Subjects do not have a GU disease
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