Photodynamic Transurethral Resection of the Bladder (TUR-B)OPTIC-IIINCT02012036
Study To Optimize Photodynamic Transurethral Resection of the Bladder (TUR-B) In Clinical Practice
An observational study of Photodynamic Transurethral Resection of the Bladder (TUR-B), run by Ipsen at 2 sites in Germany.
Trial summary
The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photodynamic Transurethral Resection of the Bladder (TUR-B)
- What is being tested?
- Hexvix
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2013to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bladder cancer patients
Who may be able to join
- Indication of TURB due to suspicion of NMIBC (patients suspected to have non muscle invasive bladder cancer).
- Subject able to comply with the protocol.
- Written informed consent available.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients of the solvent.
- Porphyria.
- Gross haematuria.
- Women of child-bearing potential.
- Repeated TURB (control TURB) as part of follow-up after previous TURB.
- Bacillus Calmette-Guerin (BCG) or Mitomycin / intravesical chemotherapy instillation therapy in the last 12 weeks or any other contraindications according to the SmPC.
- Subjects not able to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Caritas-Krankenhaus St. Josef, Klinik fuer Urologie
Regensburg, 93059
Klinikverbund Südwest
Sindelfingen, 71065
About this study
Official title: OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice
The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.
- Being tested
- Hexvix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexvixDrug
Also called hexyl aminolevulinate (HAL)
As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study.
The detection with Hexvix should be in accordance with local Summary of Product Characteristics [SmPC].
Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required.
| Study group | Role | What they receive |
|---|---|---|
| TUR-B | TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC). Receives: Drug: Hexvix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate
Detection rate is defined as number of lesions detected or not (Detection by HAL cystoscopy compared to white light cystoscopy confirmed by histology).
Measured: At TUR-B visit, up to 1 year
Secondary outcomes (2)
Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score
Risk groups are low, intermediate and high.
Measured: At TUR-B visit, up to 1 year
Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations
Measured: At TUR-B visit, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodynamic Transurethral Resection of the Bladder (TUR-B)Studies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012036
- Sponsor's protocol ID
- A-94-58150-002
- Acronym
- OPTIC-III
- Status last verified
- Aug 2019
- First submitted
- 28 Nov 2013
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice
- ClinicalTrials.gov ID
- NCT02012036
- Acronym / sponsor ID
- OPTIC-III / A-94-58150-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Dec 2013 (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.
The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TUR-B | – | Drug: HexvixTUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bladder cancer patients
Key inclusion criteria (3 listed)
- Indication of TURB due to suspicion of NMIBC (patients suspected to have non muscle invasive bladder cancer).
- Subject able to comply with the protocol.
- Written informed consent available.
Key exclusion criteria (7 listed)
- Hypersensitivity to the active substance or to any of the excipients of the solvent.
- Porphyria.
- Gross haematuria.
- Women of child-bearing potential.
- Repeated TURB (control TURB) as part of follow-up after previous TURB.
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 |
|---|---|---|
| HexvixAlso: hexyl aminolevulinate (HAL)As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study. The detection with Hexvix should be in accordance with local Summary of Product Characteristics [SmPC]. Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required. | Drug | TUR-B |
Primary outcome
Detection rate
Time frame: At TUR-B visit, up to 1 year
Detection rate is defined as number of lesions detected or not (Detection by HAL cystoscopy compared to white light cystoscopy confirmed by histology).
2 secondary outcomes
Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score
Time frame: At TUR-B visit, up to 1 year
Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations
Time frame: At TUR-B visit, up to 1 year
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 16 Aug 2019.
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.
Ipsen Medical Director study director
Ipsen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Photodynamic Transurethral Resection of the Bladder (TUR-B), run by Ipsen at 2 sites in Germany.
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 7 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Detection rate (time frame: At TUR-B visit, up to 1 year). 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 16 Aug 2019.