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

INTRODUCTION

  • Org Study ID: GCO 20-1053
  • Secondary ID: STUDY-20-01467
  • NTC 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 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

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

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: N/A

Maximum Age: 40 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ashutosh K Tewari, MD

Role: Principal Investigator

Affiliation: Icahn School of Medicine at Mount Sinai

Overall Contact

Name: Ashutosh K Tewari, MD

Phone: 212-241-3233

Email: dimple.chakravarty@mountsinai.org

LOCATION

Facility Status Contact
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact:
Kamala Bhatt, MBA
212-241-5745
kamala.bhatt@mountsinai.org