NCT02238574

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

Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	surgery	excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity
OTHER	follow up	Intensified outpatient follow up (16 visits in 5 years)

Timeline

• Primary completion: 2016-01-01
• Completion: 2024-12-01
• First posted: 2014-09-12
• Last updated: 2018-01-09

Locations

1 site across 1 country: Netherlands