Molecular and Genomic Profiling of Head and Neck Tumors

Head and Neck Neoplasms Clinical Trial

Official title:

Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00200486
• Other study ID #: 02-05-127E
• Secondary ID: NIH-R21-CA104402
• Status: Recruiting
• Start date: May 2002
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: Stelby Augustine, RN
• Phone: 718-920-7054
• Email: staugust[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome

Description:

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 and other techniques for looking at genetic and molecular characteristics, a more detailed knowledge of the malignant transformation process, and alterations with therapy, in these patients may be obtained. This study will seek to perform comprehensive molecular and genetic profiling to improve biomarker development in HNSCC and correlate this data with patient 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 specimen

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	Stelby Augustine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile		5 years
Secondary	identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins		variable