Bladder CancerSTARTNCT06205277
Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
An observational study of Bladder Cancer and Non Muscle Invasive Bladder Cancer, run by University of Trieste at 1 site in Italy.
Trial summary
The START study is a multicentre retrospective project. The aim is to identify clinico-pathological predictors of residual tumor at time of second transurethral resection of bladder tumor (re-TURBt) and to identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Non Muscle Invasive Bladder Cancer
- What is being tested?
- Second TURBt
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All pT1 NMIBC patients after a macroscopically completed first TURBt who underwent second TURBt within 6-8 weeks as per current EAU Guidelines.
Who may be able to join
- patients undergoing second TURBt (re-TURBt) for pT1LG/HG NMIBC after a macroscopically completed first TURBt (in patients with multiple lesions only the index lesion pT1 conditioning the indication of re-TURBt will be considered). Therefore, presence of residual tumor or not at time of re-TURBt will be assessed at site of previous pT1.
- patients able to provide written informed consent;
- clinical-localized non-metastatic disease (cN0, cM0).
Who cannot join
- patients with clinical non-localized BCa (cN+, cM+);
- patients with incomplete resection at time of first TURBt according to surgeon: macroscopic evidence of residual tumor, too long resection requiring a second-look will be excluded from the current study;
- patients with incomplete clinical or demographic or pathological data;
- patients who were unable to provide written informed consent;
- patients who underwent urgency or emergency procedures in life-threating scenario
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Trieste - Azienda Ospedaliera Universitaria Giuliano Isontina
Trieste, Friuli Venezia Giulia, 34149
About this study
The START study is a multicentre retrospective project. The aim is to identify clinico-pathological predictors of residual tumor at time of second transurethral resection of bladder tumor (re-TURBt) and to identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.
Read the detailed description
Background
Transurethral resection of bladder tumor (TURBt) is the standard procedure for bladder cancer (BCa) diagnosis and represents, at the same time, the most important therapeutic moment for patients with non muscle-invasive bladder cancer (NMIBC). A second or re-staging TURBt (re-TURBt), performed within 2 - 6 weeks from the initial TURBt, is currently recommended in all patients harboring tumor invasion into the lamina propria (pT1). The importance of re-TURBT lies not only in the inadequacy of the initial resection but also in its ability in providing additional prognostic information essential for risk-stratification refining.
However, it should be underlined that re-TURBt is an invasive and morbid procedure that severely affects patients' quality of life as it has to be performed on a elderly subset of patients that is maybe still suffering from the consequences of the previous surgery. Moreover, re-TURBt represents a costly procedure and a non-negligible source of logistic difficulties since it has to be scheduled within 2 to 6 weeks from the previous resection, making waiting lists longer especially for non-high-volume centers.
For all these reasons, not all the published literature agrees on the value of re-TURBt. Recently many authors focused their attention to this debated topic, questioning whether the technique used for resection, the timing of the resection itself, or the presence of CIS or the presence of detrusor muscle in the first sampling could impact on the presence of residual disease at second TURBt.
As a cornerstone in the management of high-risk NMIBC patients, recently it was pointed out as re-TURBt could be safely spared in some cases in favor of immediate conservative or radical treatments as timing a crucial crossroad in BCa landscape.
Here, a multicentre cohort of 321 patients found that the presence of detrusor muscle at first TURBt specimen, the absence of concomitant CIS and the en-bloc resection technique were independent predictors of negative histology at re-TURBt.
Bearing this in mind, the aim of this multicentre study is to identify predictors of residual tumor at re-TURBt and to further explore their clinical applicability within a risk-adapted strategy to identify patients who can be safely spared from this procedure.
Hypothesis Residual disease at time of re-TURBt has distinct patterns of presentation.
Study Aims To define clinico-pathological predictors of residual tumor at time of re-TURBt. To identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.
Outcome Measures Primary Objectives: to explore the rate of influence and the impact on residual tumor at re-TURBt among: clinical and demographic variables, preoperatory systemic inflammatory markers, surgical determinants, and pathological features.
Secondary Objectives: to test the applicability and validity of such predictors into a nomogram to identify who could be safely spared from re-TURBt.
- Conditions
- Bladder Cancer, Non Muscle Invasive Bladder Cancer
- Being tested
- Second TURBt
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second TURBtProcedure or surgery
Second TURBt for pT1 NMIBC as per current EAU Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pT1 NMIBC who underwent second TURBt | Patients with pT1 NMIBC who underwent second TURBt after a macroscopically completede first TURBt within 6-8 weeks Receives: Procedure: Second TURBt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with histologically confirmed evidence of residual tumor at second TURBt
Patients with histologically confirmed evidence of residual tumor at second TURBt defined as any pT BCa
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Claps, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205277
- Sponsor's protocol ID
- 113/21
- Acronym
- START
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT06205277
- Acronym / sponsor ID
- START / 113/21
- Conditions
- Bladder Cancer, Non Muscle Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jan 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.
The START study is a multicentre retrospective project. The aim is to identify clinico-pathological predictors of residual tumor at time of second transurethral resection of bladder tumor (re-TURBt) and to identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.
Detailed description
Background
Transurethral resection of bladder tumor (TURBt) is the standard procedure for bladder cancer (BCa) diagnosis and represents, at the same time, the most important therapeutic moment for patients with non muscle-invasive bladder cancer (NMIBC). A second or re-staging TURBt (re-TURBt), performed within 2 - 6 weeks from the initial TURBt, is currently recommended in all patients harboring tumor invasion into the lamina propria (pT1). The importance of re-TURBT lies not only in the inadequacy of the initial resection but also in its ability in providing additional prognostic information essential for risk-stratification refining.
However, it should be underlined that re-TURBt is an invasive and morbid procedure that severely affects patients' quality of life as it has to be performed on a elderly subset of patients that is maybe still suffering from the consequences of the previous surgery. Moreover, re-TURBt represents a costly procedure and a non-negligible source of logistic difficulties since it has to be scheduled within 2 to 6 weeks from the previous resection, making waiting lists longer especially for non-high-volume centers.
For all these reasons, not all the published literature agrees on the value of re-TURBt. Recently many authors focused their attention to this debated topic, questioning whether the technique used for resection, the timing of the resection itself, or the presence of CIS or the presence of detrusor muscle in the first sampling could impact on the presence of residual disease at second TURBt.
As a cornerstone in the management of high-risk NMIBC patients, recently it was pointed out as re-TURBt could be safely spared in some cases in favor of immediate conservative or radical treatments as timing a crucial crossroad in BCa landscape.
Here, a multicentre cohort of 321 patients found that the presence of detrusor muscle at first TURBt specimen, the absence of concomitant CIS and the en-bloc resection technique were independent predictors of negative histology at re-TURBt.
Bearing this in mind, the aim of this multicentre study is to identify predictors of residual tumor at re-TURBt and to further explore their clinical applicability within a risk-adapted strategy to identify patients who can be safely spared from this procedure.
Hypothesis Residual disease at time of re-TURBt has distinct patterns of presentation.
Study Aims To define clinico-pathological predictors of residual tumor at time of re-TURBt. To identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.
Outcome Measures Primary Objectives: to explore the rate of influence and the impact on residual tumor at re-TURBt among: clinical and demographic variables, preoperatory systemic inflammatory markers, surgical determinants, and pathological features.
Secondary Objectives: to test the applicability and validity of such predictors into a nomogram to identify who could be safely spared from re-TURBt.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pT1 NMIBC who underwent second TURBt | – | Procedure: Second TURBtPatients with pT1 NMIBC who underwent second TURBt after a macroscopically completede first TURBt within 6-8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All pT1 NMIBC patients after a macroscopically completed first TURBt who underwent second TURBt within 6-8 weeks as per current EAU Guidelines.
Key inclusion criteria (3 listed)
- patients undergoing second TURBt (re-TURBt) for pT1LG/HG NMIBC after a macroscopically completed first TURBt (in patients with multiple lesions only the index lesion pT1 conditioning the indication of re-TURBt will be considered). Therefore, presence of residual tumor or not at time of re-TURBt will be assessed at site of previous pT1.
- patients able to provide written informed consent;
- clinical-localized non-metastatic disease (cN0, cM0).
Key exclusion criteria (5 listed)
- patients with clinical non-localized BCa (cN+, cM+);
- patients with incomplete resection at time of first TURBt according to surgeon: macroscopic evidence of residual tumor, too long resection requiring a second-look will be excluded from the current study;
- patients with incomplete clinical or demographic or pathological data;
- patients who were unable to provide written informed consent;
- patients who underwent urgency or emergency procedures in life-threating scenario
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 |
|---|---|---|
| Second TURBtSecond TURBt for pT1 NMIBC as per current EAU Guidelines. | Procedure or surgery | Patients with pT1 NMIBC who underwent second TURBt |
Primary outcome
Patients with histologically confirmed evidence of residual tumor at second TURBt
Time frame: 6 to 8 weeks
Patients with histologically confirmed evidence of residual tumor at second TURBt defined as any pT BCa
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 12 Jan 2024.
- 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.
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?
An observational study of Bladder Cancer and Non Muscle Invasive Bladder Cancer, run by University of Trieste at 1 site in Italy.
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 3 inclusion and 5 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 12 Jan 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 Italy. 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?
Patients with histologically confirmed evidence of residual tumor at second TURBt (time frame: 6 to 8 weeks). 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 12 Jan 2024.