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Impact of COVID-19 on GU Disease

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ClinicalTrials.gov Identifier: NCT04761107
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ashutosh Kumar Tewari, 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.

Condition or disease
COVID-19 Infection Genitourinary Cancer Benign Urologic Conditions

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

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Study Type : Observational
Estimated Enrollment : 15240 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Proportion of patients with a new diagnosis of GU [ Time Frame: Day 1 ]
    Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2


Secondary Outcome Measures :
  1. Proportion of GU cancer patients, with active disease or in remission [ Time Frame: Day 1 ]
    Proportion of GU cancer patients, with active disease or in remission and with active or past infection with SARS-Co-V-2

  2. Proportion of patients with the benign urologic condition [ Time Frame: Day 1 ]
    Proportion of patients with the benign urologic condition and with active or past infection with SARS-Co-V-2


Biospecimen Retention:   Samples With DNA
  1. Peripheral blood - plasma and serum for PBMCs and aliquots.
  2. Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients seen in the Urology Department at Mount Sinai.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761107


Contacts
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Contact: Dimple Chakravarty, PhD 212-241-3233 dimple.chakravarty@mountsinai.org
Contact: Kamala Bhatt, MBA 212-241-5745 kamala.bhatt@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Kamala Bhatt, MBA    212-241-5745    kamala.bhatt@mountsinai.org   
Contact: Cristina Pasat-karasik, RN    347-466-2783    Cristina.Pasat-karasik@mountsinai.org   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ashutosh K Tewari, MD Icahn School of Medicine at Mount Sinai
Study Director: Dimple Chakravarty, PhD Icahn School of Medicine at Mount Sinai
Study Director: Sujit S Nair, PhD Icahn School of Medicine at Mount Sinai
Publications:
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Responsible Party: Ashutosh Kumar Tewari, Professor and System Chair, Urology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04761107    
Other Study ID Numbers: GCO 20-1053
STUDY-20-01467 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai:
COVID-19 Infection
Biomarkers
Prostate cancer, BPH
Bladder cancer, Urinary tract infection
Kidney stone, Kidney cancer
Malignant disease
Additional relevant MeSH terms:
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Infection
Urogenital Neoplasms
Neoplasms by Site
Neoplasms