Impact of COVID-19 on GU Disease

Active, not recruiting

• Conditions: Benign Urologic Conditions; Genitourinary Cancer; COVID-19 Infection

• Registration Number: NCT04761107
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

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 Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study Start: 2021-02-18
• Study First Posted: 2021-02-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States