Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
NCT ID: NCT05176145
Last Updated: 2023-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2022-04-05
2025-05-31
Brief Summary
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Detailed Description
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The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single arm
Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology
VisioCyt®
* Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines.
* Urine collection for conventional cytology and VisioCyt® test
Interventions
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VisioCyt®
* Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines.
* Urine collection for conventional cytology and VisioCyt® test
Eligibility Criteria
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Inclusion Criteria
* Patient understanding national language well and able to understand the protocol.
* Patient information and informed consent signature before the start of the study
* Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).
Exclusion Criteria
* Age \<18 years old
* Person deprived of liberty or under guardianship (including curatorship)
* Bladder cancer outside of urothelial carcinoma
* Associated high urinary tract carcinoma
* Kidney transplant patient (BK virus)
* Pelvic radiotherapy patient (prostate cancer)
* Patients with or under surveillance of a muscle-infiltrating bladder tumor
18 Years
ALL
No
Sponsors
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FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
UNKNOWN
Vitadx
OTHER
Responsible Party
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Locations
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Hôpital Académique ERASME
Anderlecht, , Belgium
CHU Angers
Angers, , France
CHU de Caen
Caen, , France
CHU de Clermont Ferrand
Clermont-Ferrand, , France
CHU Grenoble
Grenoble, , France
CHU Nantes
Nantes, , France
Hôpital Bichat-Claude Bernard,
Paris, , France
Hôpital Pitié-Salpétrière, APHP
Paris, , France
Clinique la Croix du Sud
Quint-Fonsegrives, , France
CHU de Rennes
Rennes, , France
CHU Strasbourg
Strasbourg, , France
Hopital Foch
Suresnes, , France
CHU Toulouse
Toulouse, , France
CHU Tours
Tours, , France
Pr Maria Jose Ribal
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Thierry Roumeguere, Pr
Role: primary
Pierre Bigot
Role: primary
Xavier Tillou, Pr
Role: primary
Laurent Guy, Pr
Role: primary
Clément Sarrazin, Pr
Role: primary
Jérôme Rigaud, Pr
Role: primary
Evanguelos Xylinas, Pr
Role: primary
Rouprêt Morgan, Pr
Role: primary
Benjamin Pradere, Pr
Role: primary
Grégory Verhoest, Dr
Role: primary
Hervé Lang, Pr
Role: primary
Thierry Lebret, Pr
Role: primary
Mathieu Roumiguié, Dr
Role: primary
Franck Bruyère, Pr
Role: primary
Maria Jose Ribal, Pr
Role: primary
Other Identifiers
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DMIA-2021
Identifier Type: -
Identifier Source: org_study_id
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