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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05415631
Other study ID # PI2022_843_0014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 13, 2022
Est. completion date May 2029

Study information

Verified date May 2022
Source Centre Hospitalier Universitaire, Amiens
Contact Fabien SAINT, Pr
Phone 03 22 45 59 45
Email saint.fabien@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date May 2029
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
France Amiens University Hospital Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor detection rate of white light cystoscopy one day
Primary Tumor detection rate of Bladder-PAD cystoscopy one day
Primary Tumor false detection rate of white light cystoscopy one day
Primary Tumor false detection rate of Bladder-PAD cystoscopy one day
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