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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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8 February 2016 |
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Main ID: |
NCT02672774 |
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Date of registration:
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25/01/2016 |
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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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Novel Endoscopic Imaging Methods for the Evaluation of Blood Vessels in Gastrointestinal Cancers
IM-ANG |
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Scientific title:
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Study of Minimally Invasive Endoscopic IMaging Methods for the Evaluation of neoANGiogenesis in Gastrointestinal Cancers |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02672774 |
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Study type:
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Interventional |
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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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Romania
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Contacts
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Name:
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Dan I. Gheonea, Assoc. Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine and Pharmacy Craiova |
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Name:
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Dan I. Gheonea, Assoc. Prof. |
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Address:
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Telephone:
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+40751268731 |
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Email:
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digheonea@gmail.com |
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Affiliation:
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Name:
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Dan I. Gheonea, Assoc. Prof. |
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Address:
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Telephone:
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+4 0751 268731 |
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Email:
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digheonea@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with gastric and colorectal cancer
- Age 18 to 90 years old, men or women
- Signed informed consent for M-NBI and pCLE examinations with tissue sampling.
Exclusion Criteria:
- Failure to provide informed consent
- Prior or ongoing chemo- and/or radiotherapy
- Patients with a contraindication for GI endoscopic procedures
- Known allergy to fluorescein
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastrointestinal Neoplasms
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Colorectal Cancer
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Gastric Cancer
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Intervention(s)
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Device: Probe based confocal laser endomicroscopy
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Procedure: Magnification endoscopy with narrow band imaging
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Primary Outcome(s)
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Real-time imaging of angiogenesis in gastric and colorectal tumors by using M-NBI and pCLE examinations
[Time Frame: 15 months]
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Secondary Outcome(s)
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Validation of endoscopic imaging findings from immunohistochemical analysis with MVD calculations
[Time Frame: 24 months]
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Secondary ID(s)
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PN-II-RU-TE-2014-4-2289
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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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