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

NCT ID: NCT02149862

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

cancer

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

Group Type: EXPERIMENTAL

Urine infrared analysis

Intervention Type: 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.

control group

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

Group Type: PLACEBO_COMPARATOR

Urine infrared analysis

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim KB Bensalah, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU rennes

Rennes, , France

Countries

France

Other Identifiers

2013-A00038-37

Identifier Type: -

Identifier Source: org_study_id