Bladder CancerNCT02113501
Optimized Treatment Strategy for HighGrade1 (HGT1) Bladder Cancer Based on Substaging: a Prospective Observational Cohort Study
An observational study of Bladder Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2005to Dec 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initial HGT1 bladder cancer patients that have undergone a complete TUR and are willing to enter the protocol.
Who may be able to join
- HGT1 bladder cancer at initial diagnosis and after a complete TUR
Who cannot join
- abscence of muscularis propria in the TUR specimen
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Vall d'Hebron, Barcelona, Spain
Barcelona, Barcelona, 08035
About this study
Official title: Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study
Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. The main hypothesis is that HighGradeT1a bladder cancer can spare a second endoscopic procedure.
Read the detailed description
Only cases of initial diagnosis of HighGradeT1 and with a complete transurethral endoscopic resection (TUR) of bladder tumor) can enter this protocol. HighGradeT1a will only receive standard BCG treatment (induction and maintenance). HighGradeT1b will undergo a second transurethral endoscopic resection (TUR) after the induction of Bacillus de Calmette-Guerin (BCG) and then continue mantenaince BCG and standard follow-up.
- Conditions
- Bladder Cancer
- Keywords
- HGT1, high risk bladder cancer, substaging, repeat transurethral resection (reTUR), lamina propria
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HGT1a | HGT1a bladder cancer patients will undergo BCG induction and maintenance followed by conventional follow-up (cystoscopy and cytology at 3months and then every 6months). | |
| HGT1b | HGT1b bladder cancer patients will undergo a 2nd TUR after BCG induction. If negative, continue with maintenance BCG followed by conventional follow-up (cystoscopy and cytology every 6months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression
Measured: 5year
Secondary outcomes (1)
recurrence
Measured: 5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2005
- Primary completionDec 2013
- Study completionDec 2013
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 Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Orsola, MD, Principal investigator, Hospital Vall d'Hebron, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113501
- Sponsor's protocol ID
- HighGradeT1 Bladder Cancer HVH
- Status last verified
- Apr 2014
- First submitted
- 31 Mar 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Orsola A, Cecchini L, Raventos CX, Trilla E, Planas J, Landolfi S, de Torres I, Morote J. Risk factors for positive findings in patients with high-grade T1 bladder cancer treated with transurethral resection of bladder tumour (TUR) and bacille Calmette-Guerin therapy and the decision for a repeat TUR. BJU Int. 2010 Jan;105(2):202-7. doi: 10.1111/j.1464-410X.2009.08694.x. Epub 2009 Jun 24.
PubMed 19558557
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02113501
- Acronym / sponsor ID
- HighGradeT1 Bladder Cancer HVH
- Conditions
- Bladder Cancer
- Keywords
- HGT1, high risk bladder cancer, substaging, repeat transurethral resection (reTUR), lamina propria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Apr 2014 (estimated)
- 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.
Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. The main hypothesis is that HighGradeT1a bladder cancer can spare a second endoscopic procedure.
Detailed description
Only cases of initial diagnosis of HighGradeT1 and with a complete transurethral endoscopic resection (TUR) of bladder tumor) can enter this protocol. HighGradeT1a will only receive standard BCG treatment (induction and maintenance). HighGradeT1b will undergo a second transurethral endoscopic resection (TUR) after the induction of Bacillus de Calmette-Guerin (BCG) and then continue mantenaince BCG and standard follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGT1a | – | –HGT1a bladder cancer patients will undergo BCG induction and maintenance followed by conventional follow-up (cystoscopy and cytology at 3months and then every 6months). |
| HGT1b | – | –HGT1b bladder cancer patients will undergo a 2nd TUR after BCG induction. If negative, continue with maintenance BCG followed by conventional follow-up (cystoscopy and cytology every 6months). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initial HGT1 bladder cancer patients that have undergone a complete TUR and are willing to enter the protocol.
Key inclusion criteria (1 listed)
- HGT1 bladder cancer at initial diagnosis and after a complete TUR
Key exclusion criteria (1 listed)
- abscence of muscularis propria in the TUR specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression
Time frame: 5year
1 secondary outcome
recurrence
Time frame: 5year
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 14 Apr 2014.
- Results publication: PubMed 19558557Orsola A, Cecchini L, Raventos CX, Trilla E, Planas J, Landolfi S, de Torres I, Morote J. Risk factors for positive findings in patients with high-grade T1 bladder cancer treated with transurethral resection of bladder tumour (TUR) and bacille Calmette-Guerin therapy and the decision for a repeat TUR. BJU Int. 2010 Jan;105(2):202-7. doi: 10.1111/j.1464-410X.2009.08694.x. Epub 2009 Jun 24.
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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.
Anna Orsola, MD principal investigator
Hospital Vall d'Hebron, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 14 Apr 2014. 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 Spain. 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?
progression (time frame: 5year). 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 NCT02113501, 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 14 Apr 2014.