Bladder CancerNCT04900259
The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations
An observational study of Bladder Cancer and Covid19, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer, Covid19
- What is being tested?
- COVID-19 pandemic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic.
Who may be able to join
- Primary bladder cancer
Who cannot join
- Previous history of urinary tract tumor
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer, Covid19
- Being tested
- COVID-19 pandemic
- Keywords
- Bladder cancer, COVID-19, Transurethral resection
- Medical subject headings
- Urinary Bladder Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 pandemicBehavioural
Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Bladder Cancer | Patients diagnosed with primary bladder cancer in the COVID-19 period Receives: Behavioral: COVID-19 pandemic | |
| PreCOVID-19 Bladder Cancer | Patients diagnosed with primary bladder cancer in the preCOVID-19 period Receives: Behavioral: COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tumor stages
Rate of tumor stages in patients who diagnosed with bladder cancer
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jul 2021
- Primary completion1 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900259
- Sponsor's protocol ID
- COVIDBC2021
- Status last verified
- Sep 2021
- First submitted
- 23 May 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32532703Esperto 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.
PubMed 32549074Wallis 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.
PubMed 32414626
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations
- ClinicalTrials.gov ID
- NCT04900259
- Acronym / sponsor ID
- COVIDBC2021
- Conditions
- Bladder Cancer, Covid19
- Keywords
- Bladder cancer, COVID-19, Transurethral resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 25 May 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Bladder Cancer | – | Behavioral: COVID-19 pandemicPatients diagnosed with primary bladder cancer in the COVID-19 period |
| PreCOVID-19 Bladder Cancer | – | Behavioral: COVID-19 pandemicPatients diagnosed with primary bladder cancer in the preCOVID-19 period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic.
Key inclusion criteria (1 listed)
- Primary bladder cancer
Key exclusion criteria (2 listed)
- Previous history of urinary tract tumor
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 pandemicPatients diagnosed with primary bladder cancer by transurethral resection in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared. | Behavioural | COVID-19 Bladder Cancer, PreCOVID-19 Bladder Cancer |
Primary outcome
Rate of tumor stages
Time frame: 2 months
Rate of tumor stages in patients who diagnosed with bladder cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 32532703Heldwein 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.
- Background: PubMed 32549074Esperto 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.
- Background: PubMed 32414626Wallis 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.
- Individual participant dataSharing planned: No
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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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
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 Bladder Cancer and Covid19, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 6 Oct 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of tumor stages (time frame: 2 months). 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 NCT04900259, which also lists 3 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 6 Oct 2021.