Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
OPTIMA
1 other identifier
observational
145
1 country
1
Brief 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%. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
August 8, 2022
August 1, 2022
4.9 years
April 11, 2022
August 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Succesful laser ablations
The proportion of successful laser ablation outpatient procedures compared to failed procedures leading to standard TURBT
4 months
Secondary Outcomes (1)
VAS score
day 0
Study Arms (1)
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.
Interventions
Laser ablation of non-Muscle invasive bladder tumors in outpatient settings.
Eligibility Criteria
Patients enrolled in the follow up programme for Non-Muscle invasive Bladder Cancer in accordance with the European guidelines.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jørgen Bjerggaard Jensenlead
- University of Aarhuscollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jørgen B Jensen, Professor, MD
Skejby University Hospital: Aarhus Universitetshospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, DMSc
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 20, 2022
Study Start
May 1, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share