NCT05415631Recruiting
Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence
Augmented Bladder Tumor Detection Using the Bladder-Portable Artifact Detection System: A Multicentric Prospective Analytic Study Using Real Time Based Artificial Intelligence (IA).
Source: ClinicalTrials.gov · Last updated 15 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Today the standard for the diagnosis and monitoring of bladder tumors is bladder endoscopy. The performance of this exam is not perfect. With this work, based on artificial intelligence, the investigators wish to combine endoscopy with a complementary diagnostic tool in order to improve patient care. The main objective will be to reduce diagnostic errors / wanderings in patients treated or followed for bladder tumors, by imposing a new standard of diagnostic bladder mapping (high PPV and VPN, high precision)(primary purpose diagnostic). The secondary objective will be to homogenize and systematize the descriptive part of the lesions, and to use AI to better characterize tumor aggressiveness. The final objective being to validate a new precision tool (diagnostic companion) essential for developing and standardizing the therapeutic management of bladder tumors (correcting inter-observer heterogeneity). In this project, video frame will be first extracted from our dataset of cystoscopy videos hosted in in the Next Cloud Recherche. Selected medical image will be segmented and analyzed using our pre-trained CNN model with a feature detection algorithm to obtain features. Data will be analyzed on both patient and lesion levels. The study will assess the Bladder-PAD accuracy on the detection of bladder tumors, and its ability to predict tumor risk of recurrence and progression.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 9 Jun 2022
- Start date
- 13 May 2022
- Primary completion date
- May 2027
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Bladder cancer
- NCT number
- NCT05415631
What you commit to
- Study type: Observational
- Planned participants: 500
- From 13 May 2022 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exclusion criteria will include gross hematuria and bacillus Calmette-Guerin (BCG) treatment or chemotherapy within 3 months of inclusion
- An exception will be made if patients had received only a single course of chemotherapy immediately following TUR
Other illness
- computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)
Other
- Evidence of more than 5 tumors or more than 3 cm
- computed tomography/magnetic resonance evidence of distant metastases (lymphatic or organic)
- Patients objecting to the use of their data in the context of research.
Who the study is looking for
- unifocal primary or recurrent suspected bladder cancer with tumor size less or equal than 3 cm
- multifocal primary or recurrent suspected bladder cancer less or equal than 5 lesions and with tumor size less or equal than 3 cm.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amiens University Hospital Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.