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Molecular and Genomic Profiling of Head and Neck Tumors

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ClinicalTrials.gov Identifier: NCT00200486
Recruitment Status : Recruiting
First Posted : September 20, 2005
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy
Study Start Date : May 2002
Estimated Primary Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins [ Time Frame: variable ]

Biospecimen Retention:   Samples With DNA
  1. Tumor specimens along with normal mucosa obtained at the time of surgery for biopsy or resection of primary or recurrent tumors of the head and neck
  2. blood, urine and sputum from patients participating in the tumor collection described above

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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
Contacts and Locations

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): NCT00200486

Contact: Catherine Sarta, RN 718-920-7054 csarta@montefiore.org
Contact: Richard V Smith, MD 718-920-8488 rsmith@montefiore.org

United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Catherine Sarta, RN    718-920-7054    csarta@montefiore.org   
Contact: Richard V Smith, MD    718-920-4267    rsmith@montefore.org   
Principal Investigator: Richard V Smith, MD         
Sub-Investigator: Thomas Belbin, PhD         
Sub-Investigator: Marvin Fried, MD         
Sub-Investigator: Michael Prystowsky, MD         
Principal Investigator: Missak Haigentz, MD         
Sub-Investigator: Schiff Bradley, MD         
Sub-Investigator: Cohen Perry, MD         
Sub-Investigator: Ow Thomas, MD         
Sub-Investigator: Mehta Vikas, MD         
Sponsors and Collaborators
Montefiore Medical Center
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Richard V Smith Montefiore Medical Center
Principal Investigator: Thomas Belbin, PhD Montefiore Medical Center
More Information

Responsible Party: Richard V. Smith, MD, Vice Chairman, Otorhinolaryngology/head and neck surgery, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00200486     History of Changes
Other Study ID Numbers: 02-05-127E
6R21DE023941-03 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Richard V. Smith, MD, Montefiore Medical Center:
genetic microarray
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site