Diagnostics for the Treatment of Progressive Mucosal Lesions of the Oral Cavity: a Prospective Study

Not Applicable

Withdrawn

• Conditions: Loss of Heterozygostiy; Chromosomal Instability; Low Grade Dysplasia Oral Cavity; Fluorescence In Situ Hybridization
• Interventions: Procedure: surgery; Other: follow up

• Registration Number: NCT02238574
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a 5-year survival of \~ 50%. Malignancies of the head and neck area are (almost) always preceded by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally limited and not very inconvenient for the patient. If this precursor lesion remain untreated, it may develop into a malignancy of the head and neck. Extensive treatment will be necessary. This means loss of function of the mouth, eg chewing, speaking and swallowing.

The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying the follow up and treatment in premalignant CIN lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.

The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA markers is a reliable indicator for progression to malignancy. By intensifying the outpatient clinic follow up and treatment in premalignant lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2016-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
follow up & surgery	surgery	CIN positive with surgery and intensified follow up
follow up & surgery	follow up	CIN positive with surgery and intensified follow up
follow up	follow up	CIN positive, only intensified outpatient follow up

Primary Outcome Measures

Name	Time	Method
Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.	1 year	The primary goal of this prospective study is: 1. Demonstrating the predictive value of the detection of CIN in premalignant lesions of the oral cavity by the use of FISH for the occurrence of progression to severe dysplasia /CIS or invasive carcinoma.; 2. The prevention of progression of premalignant lesions of the oral cavity to severe dysplasia / CIS or invasive carcinoma by the treatment of selected high-risk lesions.

Secondary Outcome Measures

Name	Time	Method
Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.	1 year	The secondary objective of this study is as follows: Demonstrating the predictive value of the detection of LOH in premalignant lesions of the oral cavity by the use of DNA markers for the occurrence of progression to severe dysplasia / CIS or invasive carcinoma.

Trial Locations

Locations (1)

Maastricht Universitair Medisch Centrum (MUMC); 🇳🇱 Maastricht, Limburg, Netherlands