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

September 5, 2016 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bladder Cancer is the ninth cause of cancer worldwide, and it is still developing, due to growing risk factors such as Tobacco consumption. It has a high level of recurrence, which imposes regular screening and permanent treatment to the patient that has developed a bladder tumor.

Bladder cancer main symptom is blood in the urine, which has low specificity and sensibility. Other screening methods include cytology and image through cystoscopy. Conclusive diagnostic is performed by biopsy of the suspicious lesions. The latter methods are highly invasive.

Hence, it is necessary to develop non invasive technique for bladder cancer screening and follow up, as there is no reliable prognostic factor available. The investigators expect to improve the detection level in the urine by measuring and analyzing its absorption spectrum in the mid infrared, spectrum which provides a comprehensive image of metabolic situation.

Hence, the main objective of the study is to assess infrared spectroscopy ability to discriminate urine of a patient affected by bladder cancer from urine of reference patient. Success will be evaluated upon the discrimination level of cancer affected patient urine infrared spectrum vs. standard patient ones.

Secondary objective will be to assess the capability to detect different affection levels and tumors grade through the infrared spectrum analysis, as well as the predictive potential of the technique. The investigators may also assess the test intrinsic sensibility and specificity.

The study is planned over an 18 month period of time, to collect urine from 100 patients followed up at Rennes Hospital center for bladder cancer treatment and from a reference pool of 100 patients cured for kidney stones. All donors will be cognizant volunteers, adult from both genders. Minors, pregnant or breast feeding women, protected adults, patients also treated for other cancers, or the ones treat with a "double J" probe will not be included into the study.

Clinical data will be extracted out of patient file (sex, age, weight, size and resected tumor characteristics).

Collected urines will be submitted to the standard cytologic analysis. Resected tumors will be analyzed by Rennes hospital anatomic pathology laboratory according to standard procedure.

Collected urine sample will be stored at -80°C for further infrared analysis.

As this is a preliminary study, there is no existing data to calculate the size of a statistically relevant sample.

Hence, the investigators chose to include 100 patients of each category to fit with Rennes hospital capacities during the time of the study.

Spectra will be analyzed by visual inspection, and statistical method such as Principal Components Analysis and logistic regressions methods.

This model will allow to determine spectral area with discriminating values between both populations. The wavelength of these spectral areas will be eventually correlated to biological elements absorption to confirm their relevance.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Chu Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cancer
patients with an indication of partial or total bladder resection will have urine infrared analysis
Other: Urine infrared analysis
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.
Placebo Comparator: control group
Lithiasic patients should be operated a urinary calculation, without catheter "double J", will have urine infrared analysis
Other: Urine infrared analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infrared spectroscopy
Time Frame: the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNM system (tumor-nodes-metastasis)
Time Frame: the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion
Resected tumors will be analyzed by Rennes hospital anatomic pathology laboratory according to standard procedure
the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Karim KB Bensalah, PU-PH, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00038-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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