Clinical trial NCT04900259: The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations
Official title: The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Covid19
Keywords: Bladder cancer
COVID-19
Transurethral resection
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic.

Brief summary: In this study, investigators aim to reveal how the COVID-19 pandemic process affects primary bladder cancer presentations, tumor stages and degrees, the time elapsed between diagnosis and intervention, tumor recurrence and progression, which are oncological results.

Detailed description: The rapid spread of the 2019 coronavirus disease (COVID-19) caused by a novel betacoronavirus known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has had dramatic effects on individuals and health systems around the world. Beyond those infected with SARS-CoV-2, the intense demand for limited health system resources has led to reduced capacity, rapid depletion of healthcare systems, and hospitals becoming a source of virus transmission.

Urology associations and reference centers have issued recommendations to inform urology care during the COVID-19 outbreak. It is essential that urologists give priority to patient safety. Potential delays in the diagnosis and treatment of urological conditions and the additional burden on healthcare resources must be balanced against the risks of exposure to COVID-19. While this situation aims to conserve healthcare resources, it has created the risk of delaying cancer treatment. As a result, the transformation of health services and the increasing interest of the public in avoiding exposure to the disease has led to a decrease in the number of hospital admissions.

The effects of the pandemic on patients with bladder cancer due to a decrease in emergency room and urology clinic admissions are not clear. During the COVID-19 outbreak, the EAU (European Association of Urology) panel of non-muscle invasive bladder cancer published an evidence-based guideline. According to this guideline, four priority groups were formed and a certain period of delaying treatment was defined for patients in each group according to their priorities.

Eligibility criteria: Inclusion Criteria:

* Primary bladder cancer

Exclusion Criteria:

* Previous history of urinary tract tumor
* Chronic kidney disease

Primary outcomes:
measure: Rate of tumor stages
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Ankara Training and Resarch Hospital
name: Ali Kaan Yildiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heldwein FL, Loeb S, Wroclawski ML, Sridhar AN, Carneiro A, Lima FS, Teoh JY. A Systematic Review on Guidelines and Recommendations for Urology Standard of Care During the COVID-19 Pandemic. Eur Urol Focus. 2020 Sep 15;6(5):1070-1085. doi: 10.1016/j.euf.2020.05.020. Epub 2020 Jun 5.
citation: Esperto F, Pang KH, Albisinni S, Papalia R, Scarpa RM. Bladder Cancer at the time of COVID-19 Outbreak. Int Braz J Urol. 2020 Jul;46(suppl.1):62-68. doi: 10.1590/S1677-5538.IBJU.2020.S107.
citation: Wallis CJD, Novara G, Marandino L, Bex A, Kamat AM, Karnes RJ, Morgan TM, Mottet N, Gillessen S, Bossi A, Roupret M, Powles T, Necchi A, Catto JWF, Klaassen Z. Risks from Deferring Treatment for Genitourinary Cancers: A Collaborative Review to Aid Triage and Management During the COVID-19 Pandemic. Eur Urol. 2020 Jul;78(1):29-42. doi: 10.1016/j.eururo.2020.04.063. Epub 2020 May 3.