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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| follow up & surgery | Experimental | CIN positive with surgery and intensified follow up |
|
| follow up | Active Comparator | CIN positive, only intensified outpatient follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure | excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Borgemeester, MD | University medical centre Maastricht | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | Limburg | 6202 | Netherlands |
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| follow up | Other | Intensified outpatient follow up (16 visits in 5 years) |
|
| ID | Term |
|---|---|
| D043171 | Chromosomal Instability |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D042822 | Genomic Instability |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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