Non-Muscle Invasive Bladder CancerOPTIMANCT05337397
Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
An observational study of Non-Muscle Invasive Bladder Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.
Trial summary
Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting. Background: Non-muscle invasive bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- Laser ablation
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to 1 Apr 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients enrolled in the follow up programme for Non-Muscle invasive Bladder Cancer in accordance with the European guidelines.
Who may be able to join
- At least one tumour with a diameter > 1 cm
- Papillary/non-solid tumours
- Previous low-grade NMIBC
- Ability to understand the participant information orally and in writing, in Danish, Spanish, Czech or French respectively
- Signed consent form
Who cannot join
- Tumour diameter > 3cm
- Tumour in the prostatic urethra
- Previous CIS, high-grade disease or muscle invasive bladder cancer with no later low-grade recurrence
- Positive cytology within 3 months (testing not mandatory in patients with low-grade tumours)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Jørgen Bjerggaard Jensen, MD, +45 30915682, bjerggaard@clin.au.dk
About this study
Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting.
Background: Non-muscle invasive bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Patients affected are therefore referred to long-term or even life-long follow-up, which burdens both patients and health care system. Recurrent tumours are most frequently treated with TURBT followed by adjuvant intravesical treatment. Repeat TURBT includes a risk of morbidity from the procedure itself and from general anaesthetics, which the procedure requires. Patients with NMIBC are generally elderly, multi-morbid, and as a result, they often show a poor tolerability of general anaesthetics. Thus, the need for non-surgical treatment modalities is imminent and continuous investigations are performed in the field including active surveillance, chemoresection and device-assisted intravesical chemotherapy. Laser ablation is a technique gaining attention in the treatment of NMIBC, based on the prospects of an outpatient treatment modality, which could prove TURBT and general anaesthesia unnecessary in select patients.
Read more
Methods: The study will be conducted as a prospective feasibility study. Included patients will undergo outpatient laser ablation using the Olympus Soltive laser under local anaesthetics.
Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Motol University Hospital (Czech Republic) and Institut Universitaire du Cancer Toulouse Oncopole (France).
Data will be reported to the eCRF in the online REDCap web application. The eCRF is stored on a secure server under the responsibility of the Department of Clinical medicine at Aarhus University in Denmark.
REDCap is a secure web application for building and managing online surveys and databases. The Database will be in agreement with the laws and regulations of the Danish Data Protection Agency and EU regulations (GDPR).
The sponsor will be overall responsible for the data entry in the eCRF, and the validity of the data collected at the specific sites. Each participant will be coded with a unique patient identifier to ensure pseudo anonymity.
Perspectives: This study will be the first multinational study with focus on feasibility of outpatient laser ablation of large bladder tumours between 1-3 cm. Outpatient laser ablation of these large tumours has the potential to reduce the number of TURBTs per patient, thus easing the life of patients with non-muscle invasive bladder cancer, with fewer surgical procedures as well as reducing the overall treatment related costs for society. If thulium laser ablation proves effective, the treatment modality would be easily implemented and available based on the small size of the machinery.
Read the detailed description
The participant will be informed that they can at any time withdraw their consent without influence on their further treatment. Withdrawal can be both with regards to further recordings of data but also deletion of collected data upon request. In case of withdrawal of consent before surgery, the patient will be treated according to local guidelines and excluded from the study.
The consent form will be approved by The Regional Committees on Health Research Ethics. The investigators are obligated to ensure, that comprehensive information is provided orally and in writing to the participant.
In the case of new relevant information or the design of the study is significantly changed, the participants will be informed, and the consent form updated.
Study participants will be informed that a signed consent form grants national investigator approved project staff, direct access to study data and patient's health records. The consent form also allows inspectors from the respective national health authorities access, if requested, in order to allow the authorities to perform controls and checks.
Data management:
The study will comply with The General Data Protection Regulation and The Data Protection Act.
All data are kept confidential in a pseudo anonymized form, according to the GDPR and the Danish Data Protection Agency's guidelines. The investigators, who will code each participant enrolled in the study with a unique patient identification number, will assure this.
Information obtained on the participants is confidential and may only be disclosed if permitted by the participant through a signed consent form. The signed consent allows both sponsor, relevant investigators from the study and authorities to enter the patient file.
The data generated by the study will be available for inspection upon request by the representatives of the national and local health authorities.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- Laser ablation
- Keywords
- Laser ablation
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablationProcedure or surgery
Laser ablation of non-Muscle invasive bladder tumors in outpatient settings.
| Study group | Role | What they receive |
|---|---|---|
| Prior pTa low grade Non-Muscle invasive bladder cancer | Patient with recurrent Pta low grade Non-Muscle invasive bladder cancer, with negative urine cytology, and tumor size between 1 and 3 cm. Receives: Procedure: Laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succesful laser ablations
The proportion of successful laser ablation outpatient procedures compared to failed procedures leading to standard TURBT
Measured: 4 months
Secondary outcomes (1)
VAS score
Pain during procedure, from 0(no pain) to highest pain(10)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 May 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
- Investigators
- Jørgen B Jensen, Professor, MD, Principal investigator, Skejby University Hospital: Aarhus Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337397
- Sponsor's protocol ID
- OPTIMA
- Acronym
- OPTIMA
- Status last verified
- Aug 2022
- First submitted
- 11 Apr 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05337397
- Acronym / sponsor ID
- OPTIMA / OPTIMA
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Keywords
- Laser ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Jørgen Bjerggaard JensenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Apr 2022 (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.
Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting.
Background: Non-muscle invasive bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Patients affected are therefore referred to long-term or even life-long follow-up, which burdens both patients and health care system. Recurrent tumours are most frequently treated with TURBT followed by adjuvant intravesical treatment. Repeat TURBT includes a risk of morbidity from the procedure itself and from general anaesthetics, which the procedure requires. Patients with NMIBC are generally elderly, multi-morbid, and as a result, they often show a poor tolerability of general anaesthetics. Thus, the need for non-surgical treatment modalities is imminent and continuous investigations are performed in the field including active surveillance, chemoresection and device-assisted intravesical chemotherapy. Laser ablation is a technique gaining attention in the treatment of NMIBC, based on the prospects of an outpatient treatment modality, which could prove TURBT and general anaesthesia unnecessary in select patients.
Methods: The study will be conducted as a prospective feasibility study. Included patients will undergo outpatient laser ablation using the Olympus Soltive laser under local anaesthetics.
Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Motol University Hospital (Czech Republic) and Institut Universitaire du Cancer Toulouse Oncopole (France).
Data will be reported to the eCRF in the online REDCap web application. The eCRF is stored on a secure server under the responsibility of the Department of Clinical medicine at Aarhus University in Denmark.
REDCap is a secure web application for building and managing online surveys and databases. The Database will be in agreement with the laws and regulations of the Danish Data Protection Agency and EU regulations (GDPR).
The sponsor will be overall responsible for the data entry in the eCRF, and the validity of the data collected at the specific sites. Each participant will be coded with a unique patient identifier to ensure pseudo anonymity.
Perspectives: This study will be the first multinational study with focus on feasibility of outpatient laser ablation of large bladder tumours between 1-3 cm. Outpatient laser ablation of these large tumours has the potential to reduce the number of TURBTs per patient, thus easing the life of patients with non-muscle invasive bladder cancer, with fewer surgical procedures as well as reducing the overall treatment related costs for society. If thulium laser ablation proves effective, the treatment modality would be easily implemented and available based on the small size of the machinery.
Detailed description
The participant will be informed that they can at any time withdraw their consent without influence on their further treatment. Withdrawal can be both with regards to further recordings of data but also deletion of collected data upon request. In case of withdrawal of consent before surgery, the patient will be treated according to local guidelines and excluded from the study.
The consent form will be approved by The Regional Committees on Health Research Ethics. The investigators are obligated to ensure, that comprehensive information is provided orally and in writing to the participant.
In the case of new relevant information or the design of the study is significantly changed, the participants will be informed, and the consent form updated.
Study participants will be informed that a signed consent form grants national investigator approved project staff, direct access to study data and patient's health records. The consent form also allows inspectors from the respective national health authorities access, if requested, in order to allow the authorities to perform controls and checks.
Data management:
The study will comply with The General Data Protection Regulation and The Data Protection Act.
All data are kept confidential in a pseudo anonymized form, according to the GDPR and the Danish Data Protection Agency's guidelines. The investigators, who will code each participant enrolled in the study with a unique patient identification number, will assure this.
Information obtained on the participants is confidential and may only be disclosed if permitted by the participant through a signed consent form. The signed consent allows both sponsor, relevant investigators from the study and authorities to enter the patient file.
The data generated by the study will be available for inspection upon request by the representatives of the national and local health authorities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prior pTa low grade Non-Muscle invasive bladder cancer | – | Procedure: Laser ablationPatient with recurrent Pta low grade Non-Muscle invasive bladder cancer, with negative urine cytology, and tumor size between 1 and 3 cm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in the follow up programme for Non-Muscle invasive Bladder Cancer in accordance with the European guidelines.
Key inclusion criteria (5 listed)
- At least one tumour with a diameter > 1 cm
- Papillary/non-solid tumours
- Previous low-grade NMIBC
- Ability to understand the participant information orally and in writing, in Danish, Spanish, Czech or French respectively
- Signed consent form
Key exclusion criteria (5 listed)
- Tumour diameter > 3cm
- Tumour in the prostatic urethra
- Previous CIS, high-grade disease or muscle invasive bladder cancer with no later low-grade recurrence
- Positive cytology within 3 months (testing not mandatory in patients with low-grade tumours)
- Pregnancy
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 |
|---|---|---|
| Laser ablationLaser ablation of non-Muscle invasive bladder tumors in outpatient settings. | Procedure or surgery | Prior pTa low grade Non-Muscle invasive bladder cancer |
Primary outcome
Succesful laser ablations
Time frame: 4 months
The proportion of successful laser ablation outpatient procedures compared to failed procedures leading to standard TURBT
1 secondary outcome
VAS score
Time frame: day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Jørgen B Jensen, Professor, MD principal investigator
Skejby University Hospital: Aarhus Universitetshospital
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 Non-Muscle Invasive Bladder Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Aug 2022. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jørgen B Jensen, Professor MD (+4578452617, bjerggaard@skejby.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succesful laser ablations (time frame: 4 months). 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 8 Aug 2022.