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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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN89530459 |
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Date of registration:
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12/09/2005 |
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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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Fluorodeoxyglucose-positron emission tomography for avoidance of futile direct laryngoscopies under general anaesthesia with taking of biopsies in patients with suspicion on recurrent laryngeal carcinoma after radiotherapy
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Scientific title:
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Date of first enrolment:
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01/02/2005 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN89530459 |
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Study type:
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Interventional |
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Study design:
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Randomised, active controlled, parallel group trial (Prevention)
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Phase:
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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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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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R
de Bree |
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Address:
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Boelelaan 1117
Department of Otolaryngology /Head and Neck Surgery
Vrije University Medical Centre
1081 HV
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 444 3690 |
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Email:
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r.bree@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with clinical suspicion on recurrent laryngeal carcinoma after radiotherapy (without obvious signs of tumour), in whom a direct laryngoscopy under general anaesthesia with taking of biopsies is indicated
2. T2 - T4 laryngeal carcinoma
Exclusion criteria: 1. Aged less than 18 years
2. Pregnancy
3. Radiotherapy within the last four months
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Laryngeal carcinoma
Cancer
Laryngeal cancer
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Intervention(s)
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Selection for direct laryngoscopy with fluorodeoxyglucose-positron emission tomography (FDG-PET). Two strategy arms are compared:
1. Conventional strategy: direct laryngoscopy under general anaesthesia with taking of biopsies
2. PET based strategy: only direct laryngoscopy under general anaesthesia with taking of biopsies if FDG-PET is positive or equivocal
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Primary Outcome(s)
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Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma.
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Secondary Outcome(s)
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Key:
1. Costs
2. Operability of a recurrence
3. Surgical margins of the salvage laryngectomy
4. Quality of life
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Secondary ID(s)
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ZonMw: 945-04-311 2004/036 (projectnummer VUmc); NTR93
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Source(s) of Monetary Support
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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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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