NCT05415631 Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence
| NCT ID | NCT05415631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-05-13 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-05-13 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Evidence of more than 5 tumors or more than 3 cm * computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher) * computed tomography/magnetic resonance evidence of distant metastases (lymphatic or organic) * 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 * Patients objecting to the use of their data in the context of research.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05415631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05415631 currently recruiting?
Yes, NCT05415631 is actively recruiting participants. Contact the research team at saint.fabien@chu-amiens.fr for enrollment information.
Where is the NCT05415631 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05415631 clinical trial?
NCT05415631 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 500 participants.
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