Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence

NCT ID: NCT05415631

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2029-05-31

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.

Conditions

Bladder Cancer; Cystoscopy; Artificial Intelligence

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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)
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Amiens University Hospital

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabien SAINT, Pr

Role: CONTACT

saint.fabien@chu-amiens.fr

03 22 45 59 45

Facility Contacts

Fabien Saint, Pr

Role: primary

saint.fabien@chu-amiens.fr

03 22 45 59 45

Other Identifiers

PI2022_843_0014

Identifier Type: -

Identifier Source: org_study_id