ClinicalTrials.Veeva

Menu

Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors (VISIOCYT 1)

V

Vitadx

Status

Completed

Conditions

Bladder Cancer

Treatments

Other: VisioCyt® diagnostic test

Study type

Interventional

Funder types

Other

Identifiers

NCT02966691
2016-A00623-48

Details and patient eligibility

About

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

Full description

This clinical trial is divided into two main phases:

I. The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.

II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.

Enrollment

1,360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years

  • Patient affiliated to a social security system

  • Patient able to understand the protocol.

  • Signature of patient consent form before the start of the study

  • Negative urine culture

  • Patient for which is programmed a bladder Endoscopy for :

    • suspected bladder cancer (de novo, monitoring or relapse)
    • Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer

Exclusion criteria

  • Age <18 years
  • Ongoing Urinary tract infection untreated
  • Private person of liberty or under guardianship (including guardianship)
  • Bladder cancer excluding urothelial carcinoma
  • Carcinoma of high urinary tract, associated
  • Lithiasis pathology
  • Patient who underwent renal transplantation

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,360 participants in 3 patient groups

Patients 'sick'
Active Comparator group
Description:
The patients of this arm have a clinical signs of bladder cancer with : * a positive result of bladder endoscopy * or an negative endoscopy and a positive result of the conventional cytology The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice .This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized
Treatment:
Other: VisioCyt® diagnostic test
Patients 'healthy'
Active Comparator group
Description:
The patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology. The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized.
Treatment:
Other: VisioCyt® diagnostic test
Patients 'monitoring'
Active Comparator group
Description:
The patients of this arm have a history of bladder cancer, but the results of their follow up examinations (cytologic and endoscopic) are negative (no tumor). The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized.
Treatment:
Other: VisioCyt® diagnostic test

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems