NCT05176145

Brief Summary

European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
3 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

December 3, 2021

Last Update Submit

October 12, 2023

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Keywords

NMIBCrecurrence

Outcome Measures

Primary Outcomes (1)

  • Performance of VisioCyt® test vs conventional cytology

    Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined

    24 months

Secondary Outcomes (1)

  • Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology

    24 months

Study Arms (1)

single arm

OTHER

Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology

Device: VisioCyt®

Interventions

VisioCyt®DEVICE

* 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

single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old and autonomous
  • 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).

You may not qualify if:

  • Patients who have had total bladder resection or bladder reconstruction
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hôpital Académique ERASME

Anderlecht, 1070, Belgium

RECRUITING

CHU Angers

Angers, France

RECRUITING

CHU de Caen

Caen, 14000, France

RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital Bichat-Claude Bernard,

Paris, France

RECRUITING

Hôpital Pitié-Salpétrière, APHP

Paris, France

RECRUITING

Clinique la Croix du Sud

Quint-Fonsegrives, 31130, France

RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

Hopital Foch

Suresnes, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHU Tours

Tours, France

RECRUITING

Pr Maria Jose Ribal

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stéphanie Grojean, PhD

CONTACT

33 (0)383501921DMIA@fondation-force.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

January 4, 2022

Study Start

April 5, 2022

Primary Completion

February 1, 2025

Study Completion

May 31, 2025

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)BE(1)ES(1)