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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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16 December 2017 |
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Main ID: |
NCT03016637 |
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Date of registration:
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09/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy
PANCOBE |
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Scientific title:
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Pancreatic Core Biopsy Needle Study (PANCOBE) |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03016637 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Michael B Mortensen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital, University of Southern denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pancreatic lesion suspected of malignancy and EUS biopsy indicated
Exclusion Criteria:
- Resectable pancreatic lesions
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Intervention(s)
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Device: SharkCore (TM) FNB Exchange System
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Primary Outcome(s)
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Number of conclusive biopsies
[Time Frame: minimum 6 moths after biopsy]
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Secondary Outcome(s)
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Quality test of biopsies
[Time Frame: 2 weeks after biopsy]
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Complications
[Time Frame: 2 weeks after biopsy]
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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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