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Molecular Classification of Head and Neck Tumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy

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Head and Neck Neoplasms

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Trial Information

Molecular Classification of Head and Neck Tumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy

Previous research by our group using genetic microarray analysis of HNSCC and normal
keratinocytes has identified two distinct groups of genetic expression based on clustering
patterns of a subgroup of genes. Clinical data was summarized for each group and overall,
patient segregation by gene expression profiling was a better predictor of outcome than
clinicopathological variables. Further analysis identified 375 genes that discriminate
between the genotypic subtypes of HNSCC. Overall, our preliminary data has shown that the
pattern of global gene expression in a HNSCC specimen can be used as a predictor of
prognosis. We isolated subsets of genes showing the greatest patterns of divergence in gene
expression. We have also identified 366 over-expressed and 246 underexpressed genes when
comparing primary tumor to normal surgical margins and have identified a similar number of
genes whose expression has changed when comparing primary tumor to lymph node metastasis.
Combining these data sets we have identified genes which consistently increase or decrease
expression during progression from normal tissue to primary tumor, and subsequently to
metastatic node. We have selected several candidate genes for subsequent analysis using
HNSCC tissue arrays. Through DNA microarray analysis, a more detailed knowledge of the
malignant transformation process, and alterations with therapy, in these patients may be
obtained. This study will seek to characterize genetic profiles on 200 patients and
correlate this data with patient's clinical data. Ultimately it is hoped that tumor
specific genetic abnormalities may be identified which could provide targets for treatment
strategies such as gene therapy, immunotherapy, or other interventions.

Study Objectives:

To evaluate gene expression patterns in human head and neck squamous cell carcinoma and
correlate this with treatment response, both surgical and non-surgical.

To identify a series of diagnostic markers in blood, urine and/or sputum for head and neck
squamous cell carcinoma and study the mechanism of action of these proteins.

Inclusion Criteria:

- actual or suspected malignant or non-malignant tumors of the head and neck

- planned biopsy and/or resection, or availability of paraffin embedded or stored
frozen tumor tissue for non-genetic analysis

Exclusion Criteria:

- insufficient tissue available for both standard diagnostic evaluation and study

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Richard V Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2002

Completion Date:

March 2015

Related Keywords:

  • Head and Neck Neoplasms
  • genetic microarray
  • head and neck cancer
  • Neoplasms
  • Head and Neck Neoplasms



Montefiore Medical Center Bronx, New York  10467-2490