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

Maastricht University Medical Centre (MUMC)

Status: Withdrawn

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

Treatments: Procedure: surgery; Other: follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT02238574

NL46343.068.13

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

follow up & surgery

Experimental group

Description:

CIN positive with surgery and intensified follow up

Treatment:

Procedure: surgery

Other: follow up

follow up

Active Comparator group

Description:

CIN positive, only intensified outpatient follow up

Treatment:

Other: follow up