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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02394223 |
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Date of registration:
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16/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FFOCT for the Diagnosis of Prostate Cancer
BIOMAGIC01 |
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Scientific title:
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Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer |
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Date of first enrolment:
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January 27, 2016 |
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Target sample size:
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91 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02394223 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Nicolas Barry Delongchamps |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Patient aged 45 to 75 years old included
- - PSA level 4.0 ng/mL
- - Patient referred for trans rectal ultrasound-guided prostate biopsy with additional
MRI-targeted biopsies
- - Patient no opposed to participate in the study
- Patient affiliated to the French National Social Security System
Exclusion Criteria:
- Known prostate cancer
- Patients unable to understand the course of the study
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Patients With PSA Level 4.0 ng/mL
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Intervention(s)
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Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure
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Primary Outcome(s)
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To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation
[Time Frame: One day (biopsy procedure)]
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Secondary Outcome(s)
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To evaluate FFOCT procedure time
[Time Frame: One day (biopsy procedure)]
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To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
[Time Frame: One day (biopsy procedure)]
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To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
[Time Frame: One day (biopsy procedure)]
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To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy
[Time Frame: One day (biopsy procedure)]
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To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
[Time Frame: One day (biopsy procedure)]
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Secondary ID(s)
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AOK 13142
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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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