Bladder CancerFIRBladdNCT02149862
FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
A study testing Urine infrared analysis in people with Bladder Cancer, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Urine infrared analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients also treated for other cancers
- Lithiasic patients with catether "double J"
- Pregnant or breast feeding women
- Protected adults,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Urine infrared analysis
- 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"
- Medical subject headings
- Urinary Bladder Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine infrared analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cancer | Experimental | patients with an indication of partial or total bladder resection will have urine infrared analysis Receives: 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 Receives: Other: Urine infrared analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Resected tumors will be analyzed by Rennes hospital anatomic pathology laboratory according to standard procedure
Measured: the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim KB Bensalah, PU-PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149862
- Sponsor's protocol ID
- 2013-A00038-37
- Acronym
- FIRBladd
- Status last verified
- May 2014
- First submitted
- 13 May 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
- ClinicalTrials.gov ID
- NCT02149862
- Acronym / sponsor ID
- FIRBladd / 2013-A00038-37
- 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"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer | Experimental | Other: Urine infrared analysispatients with an indication of partial or total bladder resection will have urine infrared analysis |
| control group | Placebo comparator | Other: Urine infrared analysisLithiasic patients should be operated a urinary calculation, without catheter "double J", will have urine infrared analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients also treated for other cancers
- Lithiasic patients with catether "double J"
- Pregnant or breast feeding women
- Protected adults,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine infrared analysisCollected 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. | Other | cancer, control group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim KB Bensalah, PU-PH principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine infrared analysis in people with Bladder Cancer, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infrared spectroscopy (time frame: the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.