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

NCT ID: NCT02238574

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2024-12-31

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.

Conditions

Chromosomal Instability; Low Grade Dysplasia Oral Cavity; Loss of Heterozygostiy; Fluorescence In Situ Hybridization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

follow up & surgery

CIN positive with surgery and intensified follow up

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity

follow up

Intervention Type: OTHER

Intensified outpatient follow up (16 visits in 5 years)

follow up

CIN positive, only intensified outpatient follow up

Group Type: ACTIVE_COMPARATOR

follow up

Intervention Type: OTHER

Intensified outpatient follow up (16 visits in 5 years)

Interventions

surgery

excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity

Intervention Type: PROCEDURE

follow up

Intensified outpatient follow up (16 visits in 5 years)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maarten Borgemeester, MD

Role: STUDY_DIRECTOR

University medical centre Maastricht

Locations

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL46343.068.13

Identifier Type: -

Identifier Source: org_study_id