Molecular and Genomic Profiling of Head and Neck Tumors

NCT00200486 | Recruiting DMC

• 5 other identifiers: 02-05-127ENIH-R21-CA1044026R21DE023941-033P50DE019032-14S23U54CA274321-02S1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Neoplasms

Keywords

genetic microarray; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile

  5 years

Secondary Outcomes (1)

• identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins

  variable

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• insufficient tissue available for both standard diagnostic evaluation and study specimen

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Cancer Institute (NCI): collaborator
• Montefiore Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stelby Augustine

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 37493178 RESULT

• 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.

  PMID: 37046664 RESULT

• 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.

  PMID: 36477880 RESULT

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

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Richard V Smith, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stelby Augustine, RN

CONTACT

718-920-7054; staugust@montefiore.org

Richard V Smith, MD

CONTACT

718-920-2991; rsmith@montefiore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2002
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)