Impact of COVID-19 on GU Disease

Overview

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 Title of Study: “Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2026

Detailed 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: 1. Consenting patients for the study. 2. Screening/Baseline REDCap survey to determine their COVID-19 symptoms. 3. Blood sample collection: This will be obtained for research studies including immune monitoring assays 4. Urine sample collection for bio-marker analysis. 5. 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

Arms, Groups and Cohorts

  • GU participants with active or past infection of SARS-Co-V-2
    • GU patients from medical records with active or past infection of SARS-Co-V-2

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with a new diagnosis of GU
    • Time Frame: Day 1
    • Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2

Secondary Measures

  • Proportion of GU cancer patients, with active disease or in remission
    • Time Frame: Day 1
    • Proportion of GU cancer patients, with active disease or in remission and with active or past infection with SARS-Co-V-2
  • Proportion of patients with the benign urologic condition
    • Time Frame: Day 1
    • Proportion of patients with the benign urologic condition and with active or past infection with SARS-Co-V-2

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ashutosh Kumar Tewari, Professor and System Chair, Urology – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • Ashutosh K Tewari, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Dimple Chakravarty, PhD, Study Director, Icahn School of Medicine at Mount Sinai
    • Sujit S Nair, PhD, Study Director, Icahn School of Medicine at Mount Sinai
  • Overall Contact(s)
    • Monali Fatterpekar, PhD, 212-241-0751, monali.fatterpekar@mountsinai.org

References

Chakravarty D, Nair SS, Hammouda N, Ratnani P, Gharib Y, Wagaskar V, Mohamed N, Lundon D, Dovey Z, Kyprianou N, Tewari AK. Sex differences in SARS-CoV-2 infection rates and the potential link to prostate cancer. Commun Biol. 2020 Jul 8;3(1):374. doi: 10.1038/s42003-020-1088-9.

Lundon DJ, Kelly BD, Nair S, Bolton DM, Kyprianou N, Wiklund P, Tewari A. Early mortality risk stratification after SARS-CoV-2 infection. Med Intensiva (Engl Ed). 2020 Jul 4;45(8):e40-2. doi: 10.1016/j.medin.2020.06.011. Online ahead of print. No abstract available.

Pavlova IP, Nair SS, Kyprianou N, Tewari AK. The Rapid Coronavirus Antibody Test: Can We Improve Accuracy? Front Med (Lausanne). 2020 Sep 2;7:569. doi: 10.3389/fmed.2020.00569. eCollection 2020. No abstract available.

Theise ND, Arment AR, Chakravarty D, Gregg JMH, Jacobson IM, Jung KH, Nair SS, Tewari AK, Thurston AW, Van Drie J, Westover JB. Clinical stage molecule PT150 is a modulator of glucocorticoid and androgen receptors with antiviral activity against SARS-CoV-2. Cell Cycle. 2020 Dec;19(24):3632-3638. doi: 10.1080/15384101.2020.1859752. Epub 2020 Dec 11.

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