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
  Purpose

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
Head and Neck Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Classification of Head and Neck Tumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 400
Study Start Date: May 2002
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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, 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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200486

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

Locations
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         
Sub-Investigator: Margaret Brandwein-Gensler, MD         
Principal Investigator: Missak Haigentz, MD         
Sub-Investigator: Schiff Bradley, MD         
Sub-Investigator: Randall P Owen, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Richard V Smith Montefiore Medical Center
Principal Investigator: Thomas Belbin, PhD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Richard V. Smith, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00200486     History of Changes
Other Study ID Numbers: 02-05-127E, NIH-R21-CA104402
Study First Received: September 12, 2005
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
genetic microarray
head and neck cancer

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

ClinicalTrials.gov processed this record on July 26, 2014