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

NCT02238574 | Withdrawn DMC

• 1 other identifier: NL46343.068.13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.

  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.

  1 year

Secondary Outcomes (1)

• Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.

  1 year

Study Arms (2)

follow up & surgery

EXPERIMENTAL

CIN positive with surgery and intensified follow up

Procedure: surgery; Other: follow up

follow up

ACTIVE COMPARATOR

CIN positive, only intensified outpatient follow up

Other: follow up

Interventions

surgery PROCEDURE

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

follow up & surgery

follow up OTHER

Intensified outpatient follow up (16 visits in 5 years)

follow up; follow up & surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects ≥18 years
• premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, Limburg, 6202, Netherlands

Location

MeSH Terms

Conditions

Chromosomal Instability

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genomic Instability

Study Officials

• Maarten Borgemeester, MD

  University medical centre Maastricht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 12, 2014
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2024
• Last Updated: January 9, 2018

Record last verified: 2014-09

Locations

NL (1)