Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary TURBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- NMIBC patients
- description
- Patients with diagnosed bladder tumors seen the urology department (Urology and Nephrology Center, Mansoura University, Egypt) will be assessed for eligibility to the study and inclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study and will be provided with an informed consent form. Study participants will be enrolled, and the appropriate scheduled procedures will be performed.
- interventionNames
- Procedure: Primary TURBT
Primary outcomes (1)
- measure
- Accuracy of Xpert monitor for detection of positive repeat TURBT
- timeFrame
- 2 years
- description
- performance of Xpert BC monitor as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-repeat TURBT Xpert BC urine test (Test of the study) with results of second look biopsy whether benign or malignant (Standard test).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Ability to give informed consent. 2. Patients receiving complete resection of NMIBC during initial TURBT. 3. Patients with histopathologically NMIBC. Exclusion Criteria: * 1\. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Concomitant upper tract urothelial carcinoma (UTUC). 3. Post initial TURBT histopathology report showing any of the following; 1. Benign histopathology 2. Low risk NMIBC patients (single lesion, primary, Ta, G1) 3. Muscle invasive UC 4. Non urothelial carcinoma of the bladder 5. CIS
References
Publications (1)
- DERIVEDElsawy AA, Awadalla A, Abdullateef M, Ahmed AE, Abol-Enein H. Can repeat biopsy be skipped after initial complete resection of T1 bladder cancer? The role of a novel urinary mRNA biomarker. Urol Oncol. 2021 Jul;39(7):437.e11-437.e19. doi: 10.1016/j.urolonc.2021.02.009. Epub 2021 Mar 27. PMID 33785220