Bladder CancerPhase 4NCT03174912

In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?

A Phase 4 study testing Intravesical BCG instillation in people with Bladder Cancer and Disease Progression, run by Ankara Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and those not treated with BCG and treated with BCG… Read more about this study

Who is it for?: Ages 30 to 90 years
Conditions the study is for: Bladder Cancer, Disease Progression, Recurrent Bladder Cancer
What is being tested?: Intravesical BCG instillation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: No sites listed yet
Study dates: 1 Jan 2007to 31 Dec 2016
Phase: Phase 4
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 30 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

primary or recurrent bladder cancer
non-muscle invasive bladder cancer
at least 60 months follow-up period if progression was not determined.

Who cannot join

primary CIS,
muscle-invasive disease after second look TUR-BT
non-urothelial carcinoma of the bladder,
concomitant upper urinary tract tumor,
not able to contacted for whatever reason

About this study

Read the detailed description

Risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and progression risk.The EORTC risk table includes these factors: number of tumors,tumor size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model to be used for patients only treated with BCG instillation.This risk table includes these factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade.

There is no risk table that can be used for NMIBC patients treated or not treated with BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table only for those treated with BCG or is one of them sufficient to predict recurrence and progression in all patients?The main aim of this study was to compare the utility of the EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG and treated with BCG.

Conditions: Bladder Cancer, Disease Progression, Recurrent Bladder Cancer
Being tested: Intravesical BCG instillation
Keywords: EORTC, CUETO, bladder neoplasm, disease progression, recurrence
Medical subject headings: Urinary Bladder Neoplasms, Disease Progression, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravesical BCG instillationProcedure or surgery
ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

Study groups in NCT03174912
Study group	Role	What they receive
Group 1	Active comparator	Whole patient group (patients not treated with BCG and patients treated with BCG) Receives: Procedure: Intravesical BCG instillation
Group 2	No intervention	Patients not treated with BCG
Group 3	Active comparator	Patients treated with BCG Receives: Procedure: Intravesical BCG instillation

What is being measured

The primary outcome is the main question the study is designed to answer.

Recurrence or progression
The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression
Measured: From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 200731 Dec 2016

First posted5 Jun 2017
Study start1 Jan 2007
Primary completion31 Dec 2016
Study completion31 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03174912
Sponsor's protocol ID: 5050
Status last verified: May 2017
First submitted: 29 May 2017
Last updated: 5 Jun 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Xylinas E, Kent M, Kluth L, Pycha A, Comploj E, Svatek RS, Lotan Y, Trinh QD, Karakiewicz PI, Holmang S, Scherr DS, Zerbib M, Vickers AJ, Shariat SF. Accuracy of the EORTC risk tables and of the CUETO scoring model to predict outcomes in non-muscle-invasive urothelial carcinoma of the bladder. Br J Cancer. 2013 Sep 17;109(6):1460-6. doi: 10.1038/bjc.2013.372. Epub 2013 Aug 27.
PubMed 23982601
Xu T, Zhu Z, Zhang X, Wang X, Zhong S, Zhang M, Shen Z. Predicting recurrence and progression in Chinese patients with nonmuscle-invasive bladder cancer using EORTC and CUETO scoring models. Urology. 2013 Aug;82(2):387-93. doi: 10.1016/j.urology.2013.04.007. Epub 2013 Jun 10.
PubMed 23759377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?
ClinicalTrials.gov ID: NCT03174912
Acronym / sponsor ID: 5050
Conditions: Bladder Cancer, Disease Progression, Recurrent Bladder Cancer
Keywords: EORTC, CUETO, bladder neoplasm, disease progression, recurrence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Ankara Training and Research HospitalUniversity, hospital or other
Study start: 1 Jan 2007 (actual)
Primary completion: 31 Dec 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 5 Jun 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1	Active comparator	Procedure: Intravesical BCG instillationWhole patient group (patients not treated with BCG and patients treated with BCG)
Group 2	No intervention	–Patients not treated with BCG
Group 3	Active comparator	Procedure: Intravesical BCG instillationPatients treated with BCG

Who may qualify

Ages: 30 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

primary or recurrent bladder cancer
non-muscle invasive bladder cancer
at least 60 months follow-up period if progression was not determined.

Key exclusion criteria (5 listed)

primary CIS,
muscle-invasive disease after second look TUR-BT
non-urothelial carcinoma of the bladder,
concomitant upper urinary tract tumor,
not able to contacted for whatever reason

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
Intravesical BCG instillationıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer	Procedure or surgery	Group 1, Group 3

Primary outcome

Recurrence or progression
Time frame: From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months
The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression

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 5 Jun 2017.
Results publication: PubMed 23982601Xylinas E, Kent M, Kluth L, Pycha A, Comploj E, Svatek RS, Lotan Y, Trinh QD, Karakiewicz PI, Holmang S, Scherr DS, Zerbib M, Vickers AJ, Shariat SF. Accuracy of the EORTC risk tables and of the CUETO scoring model to predict outcomes in non-muscle-invasive urothelial carcinoma of the bladder. Br J Cancer. 2013 Sep 17;109(6):1460-6. doi: 10.1038/bjc.2013.372. Epub 2013 Aug 27.
Results publication: PubMed 23759377Xu T, Zhu Z, Zhang X, Wang X, Zhong S, Zhang M, Shen Z. Predicting recurrence and progression in Chinese patients with nonmuscle-invasive bladder cancer using EORTC and CUETO scoring models. Urology. 2013 Aug;82(2):387-93. doi: 10.1016/j.urology.2013.04.007. Epub 2013 Jun 10.
Individual participant dataSharing planned: Undecided

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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 Phase 4 study testing Intravesical BCG instillation in people with Bladder Cancer and Disease Progression, run by Ankara Training and Research Hospital.

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 3 inclusion and 5 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 5 Jun 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Recurrence or progression (time frame: From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months). 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 NCT03174912, which also lists 2 linked publications.

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 5 Jun 2017.