Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792033
Status:
RECRUITING
Last Update Posted:
2023-04-04
First Post:
2023-03-17
Brief Title:
Multicentric Prospective T1 Urinary Bladder Cancer Registry
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Multicentric Prospective T1 Urinary Bladder Cancer ROGUE-1 Registry
Status:
RECRUITING
Status Verified Date:
2023-03
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:
ROGUE-1
Brief Summary:
Synopsis Rationale Patients with T1 urinary bladder cancer UBC are at high risk for recurrence and progression However the prognosis is dependent on several concomitant factors First and foremost an accurate diagnosis is imperative for an appropriate disease management Due to conventional transurethral resection technique resulting in fragmentation and cauterization of the tissue the pathological review is often difficult and may result in under or over-staging A central pathology review of EORTC trial data found only a 43 concordance for T1 tumours compared with staging by a local pathologist Moreover risk factors such as concomitant carcinoma in situ CIS variant histology VH and lymphovascular invasion LVI have been associated with even poorer prognosis in patients with T1 UBC However there is consistent heterogeneity in reporting these features across studies
There is an unmet need for a clean prospective dataset on T1 UBC to allow an accurate risk stratification in order to aid clinical decision making
Study endpoints The primary objective of the study is to prospectively collect data on patients with primary diagnosis of T1 NMIBC in order
to investigate the therapy failure rates in patients with primary diagnosis of T1 bladder cancer
to investigate the association of clinico-pathologic features such as LVI VH and CIS tumor size and number of tumors with pathologic outcomes
to analyze the accuracy of the local pathologist assessment on the evaluation of pathology features such as tumor stage and grade substaging according to the microscopic and extensive invasion LVI VH and CIS
to investigate the inter-observer variability among different local pathologist comparing these observations with a central pathology revision performed by expert genitourinary pathologist
to develop a clinically applicable risk stratification tool which may guide physicians during patient counselling and decision-making regrading adjuvant therapies or early cystectomy
Methods Patients with primary diagnosis of UBC and scheduled for transurethral resection of bladder at international urology departments will be prospectively recruited Patients with confirmed diagnosis of T1 UBC will be included in the study All selected patients will be asked to sign a written informed consent and any locally required privacy act document authorization prior to TURB Furthermore all patients will be required to provide consent for central pathology revision
Patients will receive adjuvant treatments ie intravesical therapy or early cystectomy according to guidelines and clinical standards All data regarding these treatments will be prospectively collected during the study period or patient death
The clinical data of patients included in the study will be prospectively collected at each center and saved within an electronic case report form eCRF using the Castor platform Castor wwwcastoredccom After combining the data sets from the different centers reports will be generated for each variable identifying missing or inconsistent data Incongruities will be solved before freezing the final database Protected health information PHI will be unavailable to investigators at other sites Follow-up chart abstractions will occur at 6-month intervals until the patient is deceased lost to follow-up or the study is terminated
Pathologic specimens will be scanned and uploaded to the eCRF to allow a central pathologic revision
Rationale for patient number Recurrence rates for T1 bladder cancer are estimated to be up to 50 4 We plan to include 700 patients in the study This would allow to detect a 50 failure rate with 4 on either side of the 95 Confidence Interval proportion 050 with 95CI 046-054
Future prospects dissemination and impact A manuscript will be written and submitted for publication on a scientific journal Any formal presentation or publication of data collected from this trial will be considered as a joint publication by the investigators
Studies originating from this registry could potentially change the risk stratification and therefore the management of patients with T1 UBC
There is an unmet need for a clean prospective dataset on T1 UBC to allow an accurate risk stratification in order to aid clinical decision making
Study endpoints The primary objective of the study is to prospectively collect data on patients with primary diagnosis of T1 NMIBC in order
to investigate the therapy failure rates in patients with primary diagnosis of T1 bladder cancer
to investigate the association of clinico-pathologic features such as LVI VH and CIS tumor size and number of tumors with pathologic outcomes
to analyze the accuracy of the local pathologist assessment on the evaluation of pathology features such as tumor stage and grade substaging according to the microscopic and extensive invasion LVI VH and CIS
to investigate the inter-observer variability among different local pathologist comparing these observations with a central pathology revision performed by expert genitourinary pathologist
to develop a clinically applicable risk stratification tool which may guide physicians during patient counselling and decision-making regrading adjuvant therapies or early cystectomy
Methods Patients with primary diagnosis of UBC and scheduled for transurethral resection of bladder at international urology departments will be prospectively recruited Patients with confirmed diagnosis of T1 UBC will be included in the study All selected patients will be asked to sign a written informed consent and any locally required privacy act document authorization prior to TURB Furthermore all patients will be required to provide consent for central pathology revision
Patients will receive adjuvant treatments ie intravesical therapy or early cystectomy according to guidelines and clinical standards All data regarding these treatments will be prospectively collected during the study period or patient death
The clinical data of patients included in the study will be prospectively collected at each center and saved within an electronic case report form eCRF using the Castor platform Castor wwwcastoredccom After combining the data sets from the different centers reports will be generated for each variable identifying missing or inconsistent data Incongruities will be solved before freezing the final database Protected health information PHI will be unavailable to investigators at other sites Follow-up chart abstractions will occur at 6-month intervals until the patient is deceased lost to follow-up or the study is terminated
Pathologic specimens will be scanned and uploaded to the eCRF to allow a central pathologic revision
Rationale for patient number Recurrence rates for T1 bladder cancer are estimated to be up to 50 4 We plan to include 700 patients in the study This would allow to detect a 50 failure rate with 4 on either side of the 95 Confidence Interval proportion 050 with 95CI 046-054
Future prospects dissemination and impact A manuscript will be written and submitted for publication on a scientific journal Any formal presentation or publication of data collected from this trial will be considered as a joint publication by the investigators
Studies originating from this registry could potentially change the risk stratification and therefore the management of patients with T1 UBC
Detailed Description:
None
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