Status:

COMPLETED

Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Lead Sponsor:

Careggi Hospital

Conditions:

Bladder Tumor

Eligibility:

All Genders

18+ years

Brief Summary

To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective...

Detailed Description

Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide...

Eligibility Criteria

Inclusion

  • willingness to participate,
  • legal age,
  • full capacity to sign informed consent
  • eligibility for each surgical operation according to the best clinical practice and the urological guidelines

Exclusion

  • concomitant use of Hexaminolevulinate (Hexvix®)
  • concomitant ongoing UTIs,
  • concomitant bladder stone presence,
  • recent catheterization or persistent bladder catheterization at time of surgery,
  • concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
  • previous chemotherapy or radiotherapy of the pelvis,
  • patient refusal at informed consent.

Key Trial Info

Start Date :

November 1 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2020

Estimated Enrollment :

114 Patients enrolled

Trial Details

Trial ID

NCT04310813

Start Date

November 1 2016

End Date

March 1 2020

Last Update

March 18 2020

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