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

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ClinicalTrials.gov Identifier: NCT02238574
Recruitment Status : Withdrawn (Lack of funding)
First Posted : September 12, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chromosomal Instability Low Grade Dysplasia Oral Cavity Loss of Heterozygostiy Fluorescence In Situ Hybridization Procedure: surgery Other: follow up Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: follow up & surgery
CIN positive with surgery and intensified follow up
 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)
Active Comparator: follow up
CIN positive, only intensified outpatient follow up
 Other: follow up
Intensified outpatient follow up (16 visits in 5 years)


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity. [ Time Frame: 1 year ]

    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.


Secondary Outcome Measures :
  1. Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity. [ Time Frame: 1 year ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238574


Locations
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Netherlands
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, Limburg, Netherlands, 6202
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Director: Maarten Borgemeester, MD University medical centre Maastricht
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02238574    
Other Study ID Numbers: NL46343.068.13
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: September 2014
Additional relevant MeSH terms:
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Chromosomal Instability
Chromosome Aberrations
Pathologic Processes
Genomic Instability