COVID-19 InfectionNCT04761107
Impact of COVID-19 on GU Disease
An observational study of COVID-19 Infection and Genitourinary Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COVID-19 Infection, Genitourinary Cancer, Benign Urologic Conditions
- How many people
- 15,240 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in the Urology Department at Mount Sinai.
Who may be able to join
- 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
Who cannot join
- Men and women below 40 years of age
- Subjects do not have a GU disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases
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.
Read the 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:
- 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
- Keywords
- COVID-19 Infection, Biomarkers, Prostate cancer, BPH, Bladder cancer, Urinary tract infection, Kidney stone, Kidney cancer, Malignant disease
- Medical subject headings
- COVID-19, Urogenital Neoplasms, Prostatic Neoplasms, Prostatic Hyperplasia, Urinary Bladder Neoplasms, Urinary Tract Infections, Kidney Calculi, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a new diagnosis of GU
Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2
Measured: Day 1
Secondary outcomes (2)
Proportion of GU cancer patients, with active disease or in remission
Proportion of GU cancer patients, with active disease or in remission and with active or past infection with SARS-Co-V-2
Measured: Day 1
Proportion of patients with the benign urologic condition
Proportion of patients with the benign urologic condition and with active or past infection with SARS-Co-V-2
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start18 Feb 2021
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai
- Investigators
- Ashutosh K Tewari, MD, Principal investigator, Icahn School of Medicine at Mount SinaiDimple Chakravarty, PhD, Study director, Icahn School of Medicine at Mount SinaiSujit S Nair, PhD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761107
- Sponsor's protocol ID
- GCO 20-1053
- Other IDs
- STUDY-20-01467
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2021
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 32641750Lundon 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.
PubMed 32912654Pavlova 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.
PubMed 32984390Theise 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.
PubMed 33305659
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases
- ClinicalTrials.gov ID
- NCT04761107
- Acronym / sponsor ID
- GCO 20-1053
- Keywords
- COVID-19 Infection, Biomarkers, Prostate cancer, BPH, Bladder cancer, Urinary tract infection, Kidney stone, Kidney cancer, Malignant disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,240 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the Urology Department at Mount Sinai.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Men and women below 40 years of age
- Subjects do not have a GU disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Proportion of GU cancer patients, with active disease or in remission
Time frame: Day 1
Proportion of patients with the benign urologic condition
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 32641750Chakravarty 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.
- Background: PubMed 32912654Lundon 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.
- Background: PubMed 32984390Pavlova 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.
- Background: PubMed 33305659Theise 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashutosh K Tewari, MD principal investigator
Icahn School of Medicine at Mount Sinai
Dimple Chakravarty, PhD study director
Icahn School of Medicine at Mount Sinai
Sujit S Nair, PhD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection and Genitourinary Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a new diagnosis of GU (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.