Molecular and Genomic Profiling of Head and Neck Tumors

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stelby Augustine, RN; Phone Number: 718-920-7054; Email: staugust@montefiore.org
• Study Contact Backup: Name: Richard V Smith, MD; Phone Number: 718-920-2991; Email: rsmith@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Stelby Augustine
      • Contact: Stelby Augustine, RN; Phone Number: 718-920-7054; Email: staugust@montefiore.org
      • Contact: Richard V Smith, MD; Phone Number: 718-920-2991; Email: rsmith@montefore.org
      • Principal Investigator: Richard V Smith, MD
      • Sub-Investigator: Thomas Belbin, PhD
      • Sub-Investigator: Michael Prystowsky, MD
      • Sub-Investigator: Schiff Bradley, MD
      • Sub-Investigator: Cohen Perry, MD
      • Principal Investigator: Ow Thomas, MD
      • Sub-Investigator: Mehta Vikas, MD
      • Sub-Investigator: Nicolas F Schlecht, PhD, MSC
      • Sub-Investigator: Geoffrey Childs, MD
      • Sub-Investigator: Madhur K Garg, MD
      • Sub-Investigator: Missak Haigentz, MD
      • Sub-Investigator: Gregory Rosenblatt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with tumors of the head and neck who ar ehaving diagnostic biopsy or surgical resection of primary lesions or recurrences

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins	variable

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institutes of Health (NIH); National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Richard V Smith, MD, Montefiore Medical Center; Principal Investigator: Thomas J Ow, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimated): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: head and neck cancer; genetic microarray
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 02-05-127E; NIH-R21-CA104402; 6R21DE023941-03 (U.S. NIH Grant/Contract); 3P50DE019032-14S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO