FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors

NCT02149862 | Completed

• 1 other identifier: 2013-A00038-37
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is too assess infrared spectroscopy ability to discriminate urine of a patient affected by bladder cancer from urine of reference patient.

Conditions

Bladder Cancer

Keywords

Bladder cancer; Diagnostic; Infrared; Spectrum; Urina; Patients with an indication of partial or total bladder resection; or; Lithiasic patients should be operated a urinary calculation, without catheter "double J"

Outcome Measures

Primary Outcomes (1)

• infrared spectroscopy

  14 bands with a major local optimum value is retained on the spectrum. For each band, the positions and intensities of local optima are the set of explanatory variables. Discriminating threshold is estimated by validation Cross and chosen to have the best compromise between sensitivity and specificity.

  the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion

Secondary Outcomes (1)

• TNM system (tumor-nodes-metastasis)

  the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion

Study Arms (2)

cancer

EXPERIMENTAL

patients with an indication of partial or total bladder resection will have urine infrared analysis

Other: Urine infrared analysis

control group

PLACEBO COMPARATOR

Lithiasic patients should be operated a urinary calculation, without catheter "double J", will have urine infrared analysis

Other: Urine infrared analysis

Interventions

Urine infrared analysis OTHER

Collected urine sample will be stored at -80°C for further infrared analysis. Spectra will be analyzed by visual inspection, and statistical method such as Principal Components Analysis and logistic regressions methods.

cancer; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an indication of partial or total bladder resection
• Lithiasic patients should be operated to a urinary calculation, without catheter "double J"
• Free inform and written consent

You may not qualify if:

• Patients also treated for other cancers
• Lithiasic patients with catether "double J"
• Pregnant or breast feeding women
• Protected adults,

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karim KB Bensalah, PU-PH

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2014-05

Locations

FR (1)