FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors (FIRBladd)
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urine infrared analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring 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"
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,
Sites / Locations
- CHU rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cancer
control group
Arm Description
patients with an indication of partial or total bladder resection will have urine infrared analysis
Lithiasic patients should be operated a urinary calculation, without catheter "double J", will have urine infrared analysis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
TNM system (tumor-nodes-metastasis)
Resected tumors will be analyzed by Rennes hospital anatomic pathology laboratory according to standard procedure
Full Information
NCT ID
NCT02149862
First Posted
May 13, 2014
Last Updated
September 5, 2016
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02149862
Brief Title
FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
Acronym
FIRBladd
Official Title
FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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"
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cancer
Arm Type
Experimental
Arm Description
patients with an indication of partial or total bladder resection will have urine infrared analysis
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Lithiasic patients should be operated a urinary calculation, without catheter "double J", will have urine infrared analysis
Intervention Type
Other
Intervention Name(s)
Urine infrared analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
infrared spectroscopy
Description
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.
Time Frame
the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion
Secondary Outcome Measure Information:
Title
TNM system (tumor-nodes-metastasis)
Description
Resected tumors will be analyzed by Rennes hospital anatomic pathology laboratory according to standard procedure
Time Frame
the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim KB Bensalah, PU-PH
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Learn more about this trial
FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
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