Bladder CancerNCT04603612
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.
A study testing Primary TURBT in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Primary TURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ability to give informed consent. 2. Patients receiving complete resection of NMIBC during initial TURBT. 3. Patients with histopathologically NMIBC.
Who cannot join
- 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;
- Benign histopathology
- Low risk NMIBC patients (single lesion, primary, Ta, G1)
- Muscle invasive UC
- Non urothelial carcinoma of the bladder
- CIS
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Primary TURBT
- Keywords
- Repeat TURBT, Recurrence, mRNA
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary TURBTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Primary TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jun 2018
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Amr A Elsawy, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603612
- Sponsor's protocol ID
- AE 181020
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33785220
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04603612
- Acronym / sponsor ID
- AE 181020
- Conditions
- Bladder Cancer
- Keywords
- Repeat TURBT, Recurrence, mRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMIBC patients | Other | Procedure: Primary TURBTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Ability to give informed consent. 2. Patients receiving complete resection of NMIBC during initial TURBT. 3. Patients with histopathologically NMIBC.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary TURBTAs 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. | Procedure or surgery | NMIBC patients |
Primary outcome
Accuracy of Xpert monitor for detection of positive repeat TURBT
Time frame: 2 years
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 33785220Elsawy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr A Elsawy principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary TURBT in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Xpert monitor for detection of positive repeat TURBT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.