Gene Expression Profiles in Predicting Survival of Patients With Head and Neck Cancer

NCT00897052 | Completed DMC

• 3 other identifiers: VICC HN 0511VU-VICC-HN-0511VU-VICC-IRB-040509
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict survival of patients with head and neck cancer. PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival of patients with head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

• Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis

  at time of surgical resection

Interventions

microarray analysis GENETIC

Assay RNA obtained from archived formalin fixed paraffin embedded tissue samples

laboratory biomarker analysis OTHER

The gene expression data will be linked to the clinical information in order to generate profile of recurrence and survival as a biomarker.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prior patients who participated on clinical trial RTOG-9501

You may qualify if:

• Diagnosis of squamous cell carcinoma of the head and neck, including 1 of the following sites:
• Hypopharynx
• Larynx
• Oral cavity
• Oropharynx
• Stage II-IV disease
• Must have received treatment on clinical trial RTOG-9501
• Formalin-fixed paraffin-embedded tissue samples available

You may not qualify if:

• Not specified
• PRIOR CONCURRENT THERAPY:
• Not specified

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

To identify gene expression profile associated with survival from formalin-fixed paraffin embedded tissue samples

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Microarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques

Study Officials

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: February 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 10, 2012

Record last verified: 2012-09