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

Chromosomal Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02238574
• Other study ID #: NL46343.068.13
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2014
• Last updated: January 5, 2018
• Est. completion date: December 2024

Study information

• Verified date: September 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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.; 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	Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.	The secondary objective of this study is as follows: Demonstrating the predictive value of the detection of LOH in premalignant lesions of the oral cavity by the use of DNA markers for the occurrence of progression to severe dysplasia / CIS or invasive carcinoma.	1 year