Bladder CancerNCT06632340
Effect of Tumor Base Size in Bladder Cancer
A study testing TUR-BT in people with Bladder Cancer, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- TUR-BT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Bladder Tumor
Who cannot join
- Invasive Bladder Tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tumor Base Size on Recurrence and Progression in Non-muscle Invasise Bladder Cancer
Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.
Read the detailed description
Between March 2021 and September 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent TUR-MT were included in the study. The groups were compared in terms of age, gender, smoking, ASA, comorbidities, BMI and the number of tumors, size, stage as intraoperative and postoperative data. Patients with tumor base size <2 cm were classified as Group
1, while with tumor base size ≥2 cm were classified as Group 2. Kaplan Meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.
- Conditions
- Bladder Cancer
- Being tested
- TUR-BT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUR-BTProcedure or surgery
Transurethral resection of bladder tumor
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | tumor base size <2 cm Receives: Procedure: TUR-BT |
| Group 2 | Other | tumor base size >2 cm Receives: Procedure: TUR-BT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Measured: 2 year
Secondary outcomes (1)
progression
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Mar 2021
- Primary completion30 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Bedirhan Bayraktar, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632340
- Sponsor's protocol ID
- BCTB2024
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tumor Base Size on Recurrence and Progression in Non-muscle Invasise Bladder Cancer
- ClinicalTrials.gov ID
- NCT06632340
- Acronym / sponsor ID
- BCTB2024
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 9 Oct 2024 (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.
Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.
Detailed description
Between March 2021 and September 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent TUR-MT were included in the study. The groups were compared in terms of age, gender, smoking, ASA, comorbidities, BMI and the number of tumors, size, stage as intraoperative and postoperative data. Patients with tumor base size <2 cm were classified as Group
1, while with tumor base size ≥2 cm were classified as Group 2. Kaplan Meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: TUR-BTtumor base size <2 cm |
| Group 2 | Other | Procedure: TUR-BTtumor base size >2 cm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bladder Tumor
Key exclusion criteria (1 listed)
- Invasive Bladder Tumor
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 |
|---|---|---|
| TUR-BTTransurethral resection of bladder tumor | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Recurrence
Time frame: 2 year
1 secondary outcome
progression
Time frame: 2 year
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 16 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUR-BT in people with Bladder Cancer, 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 1 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 16 Oct 2024. 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?
Recurrence (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.