mucosal lesion premalignancy
Conditions
Interventions
Based on FISH analysis subjects will be assigned to different groups. All
lesions classified as CIN-negative will not receive any treatment and these
subjects will be seen at the outpatient clinic d
Sponsors
Keel Neus en Oorheelkunde / moleculaire celbiologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patient >= 18 years - premalignant mucosal lesion of larynx or oral cavity, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia - written informed consent
Exclusion criteria
Exclusion criteria: - former malignancy or lesion classified as severe dysplasia or CIS at the same anatomical region of the larynx or oral cavity - former therapy at the same anatomical region - insufficient biopsy material to perform FISH analysis - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint is defined as a biopsy classification as severe dysplasia, carcinoma in situ or squamous cell carcinoma ( malignant progression). Primary study parameters: - % malignant progression in the intervention group (CIN-positive lesions) - % malignant progression in the control group (CIN-positive lesions) - % malignant progression in the groep of CIN-negative lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters: Cost-effectiveness (a) From the hospital perspective concerning the extra costs per prevented case of cancer. (b) From a societal perspective concerning costs per gained Quality of Adjusted Life Year). | — |
Countries
Netherlands
Outcome results
None listed