Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603612
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-10-18
Brief Title:
The Role of mRNA-based Urine Test Xpert Bladder Cancer Monitor in Predicting the Need for Second Look Biopsy After Transurethral Resection of Non Muscle-invasive Bladder Tumor
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
The Role of mRNA-based Urine Test Xpert Bladder Cancer Monitor in Predicting the Need for Second Look Biopsy After Transurethral Resection of Non Muscle-invasive Bladder Tumor
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
The Xpert BC Monitor is an mRNA-based urinary marker test for BC surveillance which measures the levels of five target mRNAs ABL1 ANXA10 UPK1B CRH and IGF2 from a voided urine sample by real-time RT-PCR The Xpert BC Monitor automates and integrates sample processing nucleic acid amplification and the detection of target sequences
The performance of Xpert BC monitor regarding its sensitivity and negative predictive value was shown to be considerably high reaching 84 and 93 respectively Moreover this high sensitivity was maintained in low-grade 77 and Ta tumors 82 Xpert BC monitor is going to gain now a wide popularity among practitioners in surveillance of NMIBC patients due to its simplicity to do reliability and reproducibility
The investigators hypothesize that Xpert BC monitor may be a useful tool in evaluation of patients who are potentially candidates for repeat TURBT It can refine the indications of repeat biopsy by exclusion of cases with negative test
The performance of Xpert BC monitor regarding its sensitivity and negative predictive value was shown to be considerably high reaching 84 and 93 respectively Moreover this high sensitivity was maintained in low-grade 77 and Ta tumors 82 Xpert BC monitor is going to gain now a wide popularity among practitioners in surveillance of NMIBC patients due to its simplicity to do reliability and reproducibility
The investigators hypothesize that Xpert BC monitor may be a useful tool in evaluation of patients who are potentially candidates for repeat TURBT It can refine the indications of repeat biopsy by exclusion of cases with negative test
Detailed Description:
Bladder cancer BC is a common cancer worldwide and one of the most expensive to manage This disease accounts for 6-8 of all male malignancies and 2-3 in women Non muscle invasive bladder cancer NMIBC represents about 70 to 80 of bladder cancer Of these 70 present as T1 20 as Ta and 10 as carcinoma in situ CIS
Many NMIBCs are amenable to treatment with transurethral resection of bladder tumor TURBT alone However despite the therapeutic impact of TURBT bladder cancer BCa recurrence rate can be as high as 75
The significant risk of residual tumor after initial TURBT of NMIBC lesion has been demonstrated in many studies Persistent disease after resection of T1G3 tumors has been observed in nearly 33 to 53 of patients after TURB Moreover the tumor is often understaged by initial resection so the likelihood that a T1 tumor has been understaged and muscle-invasive disease is detected by second resection ranges from 4 to 25
Treatment of a Ta T1 high-grade tumor and a T2 tumor is completely different so correct staging is therefore important It has been demonstrated that a second TURBT in patients with T1G3 tumor can increase recurrence-free survival
A second look TURBT is recommended in the following situations 1- After incomplete initial TURBT 2- If there was no muscle in the specimen after initial resection 3- In all T1 tumors 4- In all G3 tumors
These findings lead to many studies which reported on the development of new methods to avoid residual tumor at initial resection as narrow band imaging versus white light imaging However such evolutions cannot omit the need for second resection
Despite its valuable role in completion the diagnosis and proper risk categorization of NMIBC Second look TURBT is still considered an accessory invasive procedure with more added surgical risks of anesthetic and surgical complication as bleeding and perforation In addition the cost issue of hospital stay and operating theatre is a major consideration Recent studies are searching for a less invasive tool that can replace or at least refine the role of second look TURBT
The Xpert BC Monitor is an mRNA-based urinary marker test for BC surveillance which measures the levels of five target mRNAs ABL1 ANXA10 UPK1B CRH and IGF2 from a voided urine sample by real-time RT-PCR The Xpert BC Monitor automates and integrates sample processing nucleic acid amplification and the detection of target sequences
The performance of Xpert BC monitor regarding its sensitivity and negative predictive value was shown to be considerably high reaching 84 and 93 respectively Moreover this high sensitivity was maintained in low-grade 77 and Ta tumors 82 Xpert BC monitor is going to gain now a wide popularity among practitioners in surveillance of NMIBC patients due to its simplicity to do reliability and reproducibility
The investigators hypothesize that Xpert BC monitor may be a useful tool in evaluation of patients who are potentially candidates for repeat TURBT It can refine the indications of repeat biopsy by exclusion of cases with negative test
Many NMIBCs are amenable to treatment with transurethral resection of bladder tumor TURBT alone However despite the therapeutic impact of TURBT bladder cancer BCa recurrence rate can be as high as 75
The significant risk of residual tumor after initial TURBT of NMIBC lesion has been demonstrated in many studies Persistent disease after resection of T1G3 tumors has been observed in nearly 33 to 53 of patients after TURB Moreover the tumor is often understaged by initial resection so the likelihood that a T1 tumor has been understaged and muscle-invasive disease is detected by second resection ranges from 4 to 25
Treatment of a Ta T1 high-grade tumor and a T2 tumor is completely different so correct staging is therefore important It has been demonstrated that a second TURBT in patients with T1G3 tumor can increase recurrence-free survival
A second look TURBT is recommended in the following situations 1- After incomplete initial TURBT 2- If there was no muscle in the specimen after initial resection 3- In all T1 tumors 4- In all G3 tumors
These findings lead to many studies which reported on the development of new methods to avoid residual tumor at initial resection as narrow band imaging versus white light imaging However such evolutions cannot omit the need for second resection
Despite its valuable role in completion the diagnosis and proper risk categorization of NMIBC Second look TURBT is still considered an accessory invasive procedure with more added surgical risks of anesthetic and surgical complication as bleeding and perforation In addition the cost issue of hospital stay and operating theatre is a major consideration Recent studies are searching for a less invasive tool that can replace or at least refine the role of second look TURBT
The Xpert BC Monitor is an mRNA-based urinary marker test for BC surveillance which measures the levels of five target mRNAs ABL1 ANXA10 UPK1B CRH and IGF2 from a voided urine sample by real-time RT-PCR The Xpert BC Monitor automates and integrates sample processing nucleic acid amplification and the detection of target sequences
The performance of Xpert BC monitor regarding its sensitivity and negative predictive value was shown to be considerably high reaching 84 and 93 respectively Moreover this high sensitivity was maintained in low-grade 77 and Ta tumors 82 Xpert BC monitor is going to gain now a wide popularity among practitioners in surveillance of NMIBC patients due to its simplicity to do reliability and reproducibility
The investigators hypothesize that Xpert BC monitor may be a useful tool in evaluation of patients who are potentially candidates for repeat TURBT It can refine the indications of repeat biopsy by exclusion of cases with negative test
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