Impact of COVID-19 on GU Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04761107|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : April 8, 2021
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|
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:
- Consenting patients for the study.
- Screening/Baseline REDCap survey to determine their COVID-19 symptoms.
- Blood sample collection: This will be obtained for research studies including immune monitoring assays
- Urine sample collection for bio-marker analysis.
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
|Study Type :||Observational|
|Estimated Enrollment :||15240 participants|
|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|
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
- 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
- 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
- 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
- Peripheral blood - plasma and serum for PBMCs and aliquots.
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
|Contact: Dimple Chakravarty, PhDemail@example.com|
|Contact: Kamala Bhatt, MBAfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Cristina Pasat-karasik, RN 347-466-2783 Cristina.Pasatfirstname.lastname@example.org|
|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|