Chromosomal instability as indicator for the treatment of progressive mucosal lesions of the oral cavity: a prospective study.

Withdrawn

• Conditions: hyperkeratosis; 10019190; hyperplasia; mild to moderate dysplasia; premalignant laesion.; 10027656

• Registration Number: NL-OMON40192
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 374

Inclusion Criteria

Subject has a minimal age of 18 years
premalignant laesion of the oropharynx, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia
Singned informed consent form

Exclusion Criteria

Prior malignancy or laesion classified as severe dysplasia or carcinoma in situ at the same anatomical location of the oropharynx.
Prior treatment of laesions at the same anatomical location of the oropharynx (ie radiotherapy)
Insufficient biopsy material to perform a FISH analysis.
Pregnancy, based on physical load (ie extra anesthaesia)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary goal of this prospective study is:<br /><br>(1) Demonstrating the predictive value of the detection of CIN in premalignant<br /><br>lesions of the oral cavity by the use of FISH for the occurrence of progression<br /><br>to severe dysplasia /CIS or invasive carcinoma.<br /><br>(2) The prevention of progression of premalignant lesions of the oral cavity to<br /><br>severe dysplasia / CIS or invasive carcinoma by the treatment of selected<br /><br>high-risk lesions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is as follows:<br /><br>(3) Demonstrating the predictive value of the detection of LOH in premalignant<br /><br>lesions of the oral cavity by the use of DNA markers for the occurrence of<br /><br>progression to severe dysplasia / CIS or invasive carcinoma.<br /><br>(4) Conducting a primary and secondary cost analysis.</p><br>