Molecular and Genomic Profiling of Head and Neck Tumors

NCT ID: NCT00200486

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-10-01
• Study Completion Date: 2030-12-31

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

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.

Conditions

Head and Neck Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard V Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Stelby Augustine

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stelby Augustine, RN

Role: CONTACT

staugust@montefiore.org

718-920-7054

Richard V Smith, MD

Role: CONTACT

rsmith@montefiore.org

718-920-2991

Facility Contacts

Stelby Augustine, RN

Role: primary

staugust@montefiore.org

718-920-7054

Richard V Smith, MD

Role: backup

rsmith@montefore.org

718-920-2991

References

Stone A, Liu J, Lin J, Schiff BA, Ow TJ, Mehta V, Smith RV. Value of Adherence to Posttreatment Follow-Up Guidelines for Head and Neck Squamous Cell Carcinoma. Laryngoscope. 2024 Feb;134(2):708-716. doi: 10.1002/lary.30909. Epub 2023 Jul 26.

Reference Type: RESULT

PMID: 37493178 (View on PubMed)

Shrivastava N, Chavez CG, Li D, Mehta V, Thomas C, Fulcher CD, Kawachi N, Bottalico DM, Prystowsky MB, Basu I, Guha C, Ow TJ. CDK4/6 Inhibition Induces Senescence and Enhances Radiation Response by Disabling DNA Damage Repair in Oral Cavity Squamous Cell Carcinoma. Cancers (Basel). 2023 Mar 28;15(7):2005. doi: 10.3390/cancers15072005.

Reference Type: RESULT

PMID: 37046664 (View on PubMed)

Li D, Thomas C, Shrivastava N, Gersten A, Gadsden N, Schlecht N, Kawachi N, Schiff BA, Smith RV, Rosenblatt G, Augustine S, Gavathiotis E, Burk R, Prystowsky MB, Guha C, Mehta V, Ow TJ. Establishment of a diverse head and neck squamous cancer cell bank using conditional reprogramming culture methods. J Med Virol. 2023 Feb;95(2):e28388. doi: 10.1002/jmv.28388.

Reference Type: RESULT

PMID: 36477880 (View on PubMed)

Other Identifiers

02-05-127E

Identifier Type: -

Identifier Source: org_study_id

NIH-R21-CA104402

Identifier Type: -

Identifier Source: secondary_id

6R21DE023941-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3P50DE019032-14S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3U54CA274321-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link