This national multi-centre study has been delayed due to Covid-19 and a resulting lock-down of the factory in France producing our equipment for sample collection and processing .The necessary equipment could not be delivered until late autumn 2020, causing a significant delay in patient inclusion and in the overall progress of the clinical trial. Based on this, a highly appreciated 6 months prolongation has been granted for the project
The project reached its' first milestone at the end of the year 2020 when all 6 hospitals participating in the multicenter study started patient inclusion. By august 2021, 331 patients had delivered samples to the study. Only patients with a histologically confirmed non-muscle invasive bladder cancer can be included in the study. However, since the first urine sample is a pre-treatment sample it needs to be collected prior to surgery and thereby prior to the pathological evaluation of tumor histology. Only patients with a confirmed non-muscle invasive bladder cancer will be eligible for the study and surveilled for the set study period. Patients with a negative histology result - where presence of bladder cancer tumor cells can not be confirmed - will be excluded from the study, in accordance with the study protocol. So far, 183 of the 331 initial patients have confirmed non-muscle invasive bladder cancer. We are awaiting histology for 22 additional patients. For 126 patients, non-muscle invasive bladder cancer cannot be confirmed. These exclusion numbers are in accordance with our previous experience from a pilot surveillance study at Aker hospital, from 2017 - 2020. With the current inclusion rate, we expect all 500 patients to be enrolled in the study by august 2022.
A joint multi-center trial meeting was arranged at Gardermoen August 20th 2020. The meeting was scheduled to standardize the patient inclusion procedure at all hospitals - after the covid-19 brake. The meeting was a mixture of physical and digital to maintain safe distance. All participating hospitals participated with their clinical responsible as well as their study nurse. The head of our user panel (E Shive) also participated in the meeting and the discussions along with the CEO of the bladder cancer society (AE Roald, also a user representative). The meeting was successful and in the following months all hospitals started patient inclusion.
A journalist from "Uro" - the magazine for bladder cancer patients (owned by the bladder cancer society) participated in parts of the meeting. The resulting piece (Uro Nr 2 - 2020, page 14-15) featured the multicenter study and interviews with the leader of the user panel Schive, urologist and clinical responsible R Wahlqvist, and the PI Lind.
In addition, two smaller workshops has been arranged by the project coordinator (H Pharo) and Aker study nurse (AK Sørbø) for all participating study nurses. The use of the urine filtration device, as well as other practicalities were addressed in the meetings.
PI Lind participated in a webinar about bladder cancer (June 17th 2020), arranged by the bladder cancer society (in collaboration with the cancer society). The target group was bladder cancer patients and next of kin. Lind was invited to talk about ongoing bladder cancer research in general, and this multicenter trial in particular, and to answer any questions from the participants.
The project has also been presented at "Kirurgisk høstmøte" 2020 and at the international conference Biomarker Week Online (arranged by Oxford Global; may 2021)
To summarize: After the covid-19 delay, inclusion of patients is now running at full speed at all participating hospitals. According to the adjusted milestones in the prolonged project period, the project is on track.
In Norway, bladder cancer is the 5th most common cancer and contributes significantly to morbidity and mortality. Despite being such a common disease, bladder cancer is under-prioritized and understudied.
The vast majority of bladder cancers are non-muscle invasive and generally have a good prognosis, but as many as 50 to 70% of the patients experience recurrence and 10-20% progress to more aggressive muscle invasive bladder cancer. Due to the high recurrence rate, bladder cancer patients are frequently surveilled by cystoscopy after curative treatment. Cystoscopy is the gold standard for both diagnosis and surveillance of bladder cancer, but is invasive with suboptimal accuracy, and the frequent use makes bladder cancer one of the most expensive cancer types to manage for society. A non-invasive urinary test based on suitable biomarkers have the potential to replace parts of the cystoscopies and contribute to improved clinical management of bladder cancer. Indeed, such a non-invasive test has been requested for a long time, from both patients and urologists, and represents the clinical practice of tomorrow with clear benefits for the patients and the society.
We have recently developed a biomarker-based urine test for detection of bladder cancer, with promising initial results. A national multi-center clinical study aiming at demonstrating the clinical utility of this test was partly granted last year from the health regions. Here we apply for coverage of the remaining costs to fully fund the study.
BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering