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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Montefiore Medical Center
Sponsor:
Collaborator:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00200486
First received: September 12, 2005
Last updated: June 27, 2011
Last verified: June 2011

September 12, 2005
June 27, 2011
May 2002
May 2013   (final data collection date for primary outcome measure)
correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00200486 on ClinicalTrials.gov Archive Site
identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins [ Time Frame: variable ] [ Designated as safety issue: No ]
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Molecular Classification of Head and Neck Tumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy
Molecular Classification of Head and Neck Tumors Using cDNA Microarray Analysis to Detect 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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
  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
Non-Probability Sample

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

Head and Neck Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
March 2015
May 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Catherine Sarta, RN 718-920-7054 csarta@montefiore.org
Contact: Richard V Smith, MD 718-920-8488 rsmith@montefiore.org
United States
 
NCT00200486
02-05-127E, NIH-R21-CA104402
Yes
Richard V. Smith, MD, Montefiore Medical Center
Montefiore Medical Center
National Institutes of Health (NIH)
Principal Investigator: Richard V Smith Montefiore Medical Center
Principal Investigator: Thomas Belbin, PhD Montefiore Medical Center
Montefiore Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP