Impact of COVID-19 on GU Disease

NCT04761107 | Active Not Recruiting DMC

• 2 other identifiers: GCO 20-1053STUDY-20-01467
• Study Type: observational
• Target: 15,240
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infection; Genitourinary Cancer; Benign Urologic Conditions

Keywords

COVID-19 Infection; Biomarkers; Prostate cancer, BPH; Bladder cancer, Urinary tract infection; Kidney stone, Kidney cancer; Malignant disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of GU cancer patients, with active disease or in remission

  Day 1

• Proportion of patients with the benign urologic condition

  Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients seen in the Urology Department at Mount Sinai.

You may qualify if:

• 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

You may not qualify if:

• Men and women below 40 years of age
• Subjects do not have a GU disease

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related 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.

  PMID: 32641750 BACKGROUND

• 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.

  PMID: 32912654 BACKGROUND

• 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.

  PMID: 32984390 BACKGROUND

• 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.

  PMID: 33305659 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Peripheral blood - plasma and serum for PBMCs and aliquots. 2. Urine

MeSH Terms

Conditions

COVID-19; Urogenital Neoplasms; Prostatic Neoplasms; Prostatic Hyperplasia; Urinary Bladder Neoplasms; Urinary Tract Infections; Kidney Calculi; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Nephrolithiasis; Kidney Diseases; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashutosh K Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Dimple Chakravarty, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Sujit S Nair, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chair, Urology

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 18, 2021
• Study Start: February 18, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)