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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: |
NCT02238574 |
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Date of registration:
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09/09/2014 |
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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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Diagnostics for the Treatment of Progressive Mucosal Lesions of the Oral Cavity: a Prospective Study
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Scientific title:
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Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity. |
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Date of first enrolment:
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December 8, 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02238574 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Maarten Borgemeester, MD |
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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 medical centre Maastricht |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- subjects =18 years
- premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia,
mild or moderate dysplasia
- written informed consent
Exclusion Criteria:
- former malignancy or lesion classified as severe dysplasia or carcinoma in situ at the
same anatomical localization of the oral cavity
- lesions within an anatomical field which has been exposed to former treatment (e.g.
radiotherapy)
- insufficient biopsy material to perform additional FISH analysis
- pregnancy, because of the physical burden (e.g. extra general anesthesia) in this
study setting
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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Chromosomal Instability
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Low Grade Dysplasia Oral Cavity
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Loss of Heterozygostiy
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Fluorescence In Situ Hybridization
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Intervention(s)
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Other: follow up
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Procedure: surgery
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Primary Outcome(s)
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Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.
[Time Frame: 1 year]
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Secondary ID(s)
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NL46343.068.13
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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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