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.

NCT04603612 | Completed

• 1 other identifier: AE 181020
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Repeat TURBT; Recurrence; mRNA

Outcome Measures

Primary Outcomes (1)

• Accuracy of Xpert monitor for detection of positive repeat TURBT

  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).

  2 years

Study Arms (1)

NMIBC patients

OTHER

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.

Procedure: Primary TURBT

Interventions

Primary TURBT PROCEDURE

As shown in (Fig. 1), all patients will be thoroughly evaluated by medical history and physical exam, laboratory investigations, abdominal pelvic ultrasound (US). Then, all patients will be managed by cystoscopy and initial complete TURBT. Patients with benign pathology, non-urothelial carcinoma or muscle invasive disease, will be excluded from the study. After 4-6 weeks, eligible patients will be appointed for repeat resection TURBT.

NMIBC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ability to give informed consent. 2. Patients receiving complete resection of NMIBC during initial TURBT. 3. Patients with histopathologically NMIBC.

You may not qualify if:

• \. 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;
• Benign histopathology
• Low risk NMIBC patients (single lesion, primary, Ta, G1)
• Muscle invasive UC
• Non urothelial carcinoma of the bladder
• CIS

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

Related Publications (1)

• Elsawy 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 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amr A Elsawy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 27, 2020
• Study Start: June 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

EG (1)