Impact of COVID-19 on GU Disease

COVID-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761107
• Other study ID #: GCO 20-1053
• Secondary ID: STUDY-20-01467
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Monali Fatterpekar, PhD
• Phone: 212-241-0751
• Email: monali.fatterpekar[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15240
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Urologic Conditions
• COVID-19
• COVID-19 Infection
• Genitourinary Cancer
• Infections
• Urogenital Neoplasms

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a new diagnosis of GU	Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2	Day 1
Secondary	Proportion of GU cancer patients, with active disease or in remission	Proportion of GU cancer patients, with active disease or in remission and with active or past infection with SARS-Co-V-2	Day 1
Secondary	Proportion of patients with the benign urologic condition	Proportion of patients with the benign urologic condition and with active or past infection with SARS-Co-V-2	Day 1