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

INTRODUCTION

  • Org Study ID: GCO 20-1053
  • Secondary ID: N/A
  • NCT ID: NCT04761107
  • 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

  • Overall Status
    Recruiting
  • Start Date
    February 18, 2021
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of patients with a new diagnosis of GU

Primary Outcome 1 - Timeframe: Day 1

CONDITION

  • C
  • G
  • B

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

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: A, D, S

Role: P, S, S

Affiliation: I, I, I

Overall Contact

Name: A, D, S

Phone: 2

Email: m

LOCATION

Facility Status Contact