Impact of COVID-19 on GU Disease

January 29, 2025 updated by: Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai

Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases

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.

Study Overview

Status

Active, not recruiting

Conditions

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

Study Type

Observational

Enrollment (Actual)

15240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients seen in the Urology Department at Mount Sinai.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Ashutosh K Tewari, MD, Icahn School of Medicine at Mount Sinai
  • Study Director: Dimple Chakravarty, PhD, Icahn School of Medicine at Mount Sinai
  • Study Director: Sujit S Nair, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 20-1053
  • STUDY-20-01467 (Other Identifier: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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