Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 September 2016 |
Main ID: |
NCT02149862 |
Date of registration:
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13/05/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors
FIRBladd |
Scientific title:
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FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors |
Date of first enrolment:
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May 2014 |
Target sample size:
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137 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02149862 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Karim KB Bensalah, PU-PH |
Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Key inclusion & exclusion criteria
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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,
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bladder Cancer
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Intervention(s)
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Other: Urine infrared analysis
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Primary Outcome(s)
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infrared spectroscopy
[Time Frame: the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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2013-A00038-37
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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