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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2020-10-27

No results posted yet for this study

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

Interventions

PROCEDURE

Primary TURBT

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amr A Elsawy · Mansoura University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-09-01
Completion
2020-10-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603612 on ClinicalTrials.gov