Impact of COVID-19 on GU Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

COVID-19 Vaccines and the Development of New LUTS

NCT05582525

COVID-19 Vaccine Adverse Reaction Lower Urinary Tract Symptoms

COMPLETED

The Global Prevalence of Infections in Urology Study

NCT03665467

Hospital Infection Urinary Tract Infections

UNKNOWN

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

NCT03077711

Urinary Tract Infections, Recurrent

COMPLETED PHASE4

Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life

NCT06163469

Neurogenic Bladder Urinary Retention

RECRUITING NA

Analysis of SARS-CoV2 Urine Viral Particles and Association With Proximal Tubular Dysfunction

NCT04937712

SARS-CoV2 Infection Proximal Tubule Dysfunction

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Infection Genitourinary Cancer Benign Urologic Conditions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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