Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205277
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2024-01-03
Brief Title:
Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
Sponsor:
University of Trieste
Organization:
University of Trieste
Study Overview
Official Title:
Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None