Bladder Cancer Clinical Trial
Official title:
FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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