Bladder CancerNCT05167916
Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?
A study testing Outpatient check cytoscopy and Urine cytology in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy. 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?
- Outpatient check cytoscopy and Urine cytology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jan 2023
- 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
- Adult patients (aged >18 years)
- Patients with primary or recurrent NMIBC for whom complete primary TURBT was done.
Who cannot join
- Patients with incomplete resection
- Patients with nonurothelial carcinoma or variant histology.
- Patient with biopsy proven muscle invasion, or Ta BC.
Trial locations and contacts
1 site in 1 country.
Mahmoud Laymon contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Urology and Nephrology Center
Al Mansurah, DK, 35516
Amr A Elsawy, 01009428750, amrelsawy.unc@hotmail.com
Mahmoud Laymon, dr_mahmoudlaymon@yahoo.com
About this study
The primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.
Read the detailed description
Non muscle invasive bladder cancer (NMIBC) represents the vast majority (70%-80 %) of bladder cancer (BC) patients. T1 disease accounts for 15% to 30 % of NMIBC and is defined as invasion of the lamina propria without invasion of the muscularis propria.
Complete primary transurethral resection of bladder tumor (TURBT) is considered a crucial initial step not only to establish the diagnosis but also to achieve good prognosis and to guard against early recurrence due to missed lesions. Most current guidelines recommend repeat biopsy at 2 to 6 weeks after initial complete resection of T1 BC before initiation of adjuvant intravesical instillation of bacillus of Calmette and Guerin (BCG).
Repeat biopsy after presumable complete primary TURBT of T1 disease is quite helpful to confirm complete resection; in addition, it can provide additional pathological information as residual T1/Ta disease in 33%-55% of patients and T2 disease (upstaging) in 3%-10% of patients.
However, repeat biopsy is still an invasive procedure adding further cost and risk of anesthetic as well as surgical complications. In addition, it was shown in a recent published report by Adam and colleagues that repeat biopsy alters further patient management in a minority of patients and delay adjuvant intravesical BCG in 90% of patients.
Therefore, ensuring adequate primary complete resection by less invasive tools might be a helpful step to spare large proportion of T1 BC patients the added cost and morbidity of repeat biopsy, and to prioritize patients for intervention in systems with long waiting times, as well.
Urine cytology is a useful noninvasive method for detection of urothelial carcinoma of the urinary bladder. It has been established as a useful adjunct in both the diagnosis and follow-up especially for high grade tumor, and carcinoma in situ (CIS).
Urine cytology after complete primary resection of NMIBC had been investigated in previous reports as a determinant factor of possible overlooked tumors after primary resection.
On the other hand, check outpatient cystoscopy under local anesthesia remains the gold standard tool of initial diagnosis and surveillance of NMIBC. However, it lacks the sensitivity to detect flat lesions (more likely CIS).
In this context, the investigators assume that combined check outpatient cystoscopy and urine cytology 4 weeks after initial complete resection of T1 BC can provide reliable information about possibility of residual tumor/s that necessities repeat biopsy.
In the current study, the investigators aim at evaluating the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.
- Conditions
- Bladder Cancer
- Being tested
- Outpatient check cytoscopy, Urine cytology
- Keywords
- Bladder cancer, Cystoscopy, Cytology, Repeat biopsy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient check cytoscopyProcedure or surgery
Four weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results.
Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both.
Urine cytologyDiagnostic test
Four weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results.
Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both.
| Study group | Role | What they receive |
|---|---|---|
| T1 Bladder cancer patients | Experimental | Not described Receives: Procedure: Outpatient check cytoscopy; Diagnostic Test: Urine cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive repeat biopsy for malignancy
The primary outcome include evaluation of the clinical performance of combined urine cytology and outpatient check cystoscopy 4 weeks after primary complete resection of T1BC as a predictive tool for possible residual malignancy at repeat biopsy.
Measured: 4 weeks
Secondary outcomes (1)
Tumor recurrence rate
The secondary outcome includes the evaluation of predictive capacity of combined urine cytology and outpatient check cystoscopy for early tumor recurrence in the study participants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
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
- NCT05167916
- Sponsor's protocol ID
- AS-12-2021
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?
- ClinicalTrials.gov ID
- NCT05167916
- Acronym / sponsor ID
- AS-12-2021
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Cystoscopy, Cytology, Repeat biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 22 Dec 2021 (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 primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.
Detailed description
Non muscle invasive bladder cancer (NMIBC) represents the vast majority (70%-80 %) of bladder cancer (BC) patients. T1 disease accounts for 15% to 30 % of NMIBC and is defined as invasion of the lamina propria without invasion of the muscularis propria.
Complete primary transurethral resection of bladder tumor (TURBT) is considered a crucial initial step not only to establish the diagnosis but also to achieve good prognosis and to guard against early recurrence due to missed lesions. Most current guidelines recommend repeat biopsy at 2 to 6 weeks after initial complete resection of T1 BC before initiation of adjuvant intravesical instillation of bacillus of Calmette and Guerin (BCG).
Repeat biopsy after presumable complete primary TURBT of T1 disease is quite helpful to confirm complete resection; in addition, it can provide additional pathological information as residual T1/Ta disease in 33%-55% of patients and T2 disease (upstaging) in 3%-10% of patients.
However, repeat biopsy is still an invasive procedure adding further cost and risk of anesthetic as well as surgical complications. In addition, it was shown in a recent published report by Adam and colleagues that repeat biopsy alters further patient management in a minority of patients and delay adjuvant intravesical BCG in 90% of patients.
Therefore, ensuring adequate primary complete resection by less invasive tools might be a helpful step to spare large proportion of T1 BC patients the added cost and morbidity of repeat biopsy, and to prioritize patients for intervention in systems with long waiting times, as well.
Urine cytology is a useful noninvasive method for detection of urothelial carcinoma of the urinary bladder. It has been established as a useful adjunct in both the diagnosis and follow-up especially for high grade tumor, and carcinoma in situ (CIS).
Urine cytology after complete primary resection of NMIBC had been investigated in previous reports as a determinant factor of possible overlooked tumors after primary resection.
On the other hand, check outpatient cystoscopy under local anesthesia remains the gold standard tool of initial diagnosis and surveillance of NMIBC. However, it lacks the sensitivity to detect flat lesions (more likely CIS).
In this context, the investigators assume that combined check outpatient cystoscopy and urine cytology 4 weeks after initial complete resection of T1 BC can provide reliable information about possibility of residual tumor/s that necessities repeat biopsy.
In the current study, the investigators aim at evaluating the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T1 Bladder cancer patients | Experimental | Procedure: Outpatient check cytoscopy, Diagnostic Test: Urine cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged >18 years)
- Patients with primary or recurrent NMIBC for whom complete primary TURBT was done.
Key exclusion criteria (3 listed)
- Patients with incomplete resection
- Patients with nonurothelial carcinoma or variant histology.
- Patient with biopsy proven muscle invasion, or Ta BC.
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 |
|---|---|---|
| Outpatient check cytoscopyFour weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results. Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both. | Procedure or surgery | T1 Bladder cancer patients |
| Urine cytologyFour weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results. Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both. | Diagnostic test | T1 Bladder cancer patients |
Primary outcome
Rate of positive repeat biopsy for malignancy
Time frame: 4 weeks
The primary outcome include evaluation of the clinical performance of combined urine cytology and outpatient check cystoscopy 4 weeks after primary complete resection of T1BC as a predictive tool for possible residual malignancy at repeat biopsy.
1 secondary outcome
Tumor recurrence rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- 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.
Mahmoud Laymon contact
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 Outpatient check cytoscopy and Urine cytology 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Elsawy (01009428750, amrelsawy.unc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive repeat biopsy for malignancy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2021.