Clinical trial NCT02238574: Diagnostics for the Treatment of Progressive Mucosal Lesions of the Oral Cavity: a Prospective Study
Official title: Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chromosomal Instability
Low Grade Dysplasia Oral Cavity
Loss of Heterozygostiy
Fluorescence In Situ Hybridization
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
state: Limburg
Study officials:
affiliation: University medical centre Maastricht
name: Maarten Borgemeester, MD
role: STUDY_DIRECTOR
References: