A prospective study to determine the value of chromosomal instability in selecting treatment of head and neck mucosal lesions.

• Conditions: mucosal lesion; premalignancy; 10027656; 10019190

• Registration Number: NL-OMON35040
• Lead Sponsor: Keel Neus en Oorheelkunde / moleculaire celbiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 760

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The endpoint is defined as a biopsy classification as severe dysplasia,<br /><br>carcinoma in situ or squamous cell carcinoma ( malignant progression).<br /><br><br /><br>Primary study parameters:<br /><br>- % malignant progression in the intervention group (CIN-positive lesions)<br /><br>- % malignant progression in the control group (CIN-positive lesions)<br /><br>- % malignant progression in the groep of CIN-negative lesions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters:<br /><br>Cost-effectiveness<br /><br>(a) From the hospital perspective concerning the extra costs per prevented case<br /><br>of cancer.<br /><br>(b) From a societal perspective concerning costs per gained Quality of Adjusted<br /><br>Life Year).</p><br>