Bladder CancerNCT04194112
Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
A study testing immediate urine cytology in people with Bladder Cancer, run by Mansoura University.
Trial summary
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence. 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?
- immediate urine cytology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 1 Sep 2019
- 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
- -patients with primary or recurrent NMIBC for whom complete TURBT was done
Who cannot join
- -Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).
About this study
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.
Read the detailed description
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.
- Conditions
- Bladder Cancer
- Being tested
- immediate urine cytology
- 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.
immediate urine cytologyDiagnostic test
Forty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT.
| Study group | Role | What they receive |
|---|---|---|
| NMIBC patients | Other | Patients with primary or recurrent NMIBC for whom complete TURBT was done. Receives: Diagnostic Test: immediate urine cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of IUC
The primary outcome included assessment of the performance of IUC as a predictive tool for possible residual malignancy after primary TURBT. Thereafter, sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV, NPV) and overall accuracy of IUC as a preliminary step before repeat TURBT will be determined.
Measured: It was assessed 48 hours after primary TURBT
Secondary outcomes (1)
The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
Measured: Within duration of follow up (4 years )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Apr 2015
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
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
- 198 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194112
- Sponsor's protocol ID
- AE 2398
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
- ClinicalTrials.gov ID
- NCT04194112
- Acronym / sponsor ID
- AE 2398
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Dec 2019 (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 current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.
Detailed description
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.
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 | Diagnostic Test: immediate urine cytologyPatients with primary or recurrent NMIBC for whom complete TURBT was done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -patients with primary or recurrent NMIBC for whom complete TURBT was done
Key exclusion criteria (1 listed)
- -Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).
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 |
|---|---|---|
| immediate urine cytologyForty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT. | Diagnostic test | NMIBC patients |
Primary outcome
Diagnostic performance of IUC
Time frame: It was assessed 48 hours after primary TURBT
The primary outcome included assessment of the performance of IUC as a predictive tool for possible residual malignancy after primary TURBT. Thereafter, sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV, NPV) and overall accuracy of IUC as a preliminary step before repeat TURBT will be determined.
1 secondary outcome
The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
Time frame: Within duration of follow up (4 years )
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 12 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing immediate urine cytology in people with Bladder Cancer, run by Mansoura University.
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 1 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnostic performance of IUC (time frame: It was assessed 48 hours after primary TURBT). 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 12 Dec 2019.