Clinical trial NCT04761107: Impact of COVID-19 on GU Disease
Official title: Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 15240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in the Urology Department 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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with a new diagnosis of GU
timeFrame: Day 1
Secondary outcomes:
measure: Proportion of GU cancer patients, with active disease or in remission
timeFrame: Day 1
measure: Proportion of patients with the benign urologic condition
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ashutosh K Tewari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Dimple Chakravarty, PhD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Sujit S Nair, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.