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NCT00897052 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Survival Prediction in HNSCC Based on Gene Expression Profiles From FFPE Tissues

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00897052
Other study ID # VICC HN 0511
Secondary ID VU-VICC-HN-0511V
Status Completed
Phase N/A
First received May 9, 2009
Last updated September 7, 2012
Start date February 2005
Est. completion date December 2007

Study information
Verified date September 2012
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Description:

OBJECTIVES:

- Identify gene expression profiles associated with survival by DNA microarray assay analysis using RNA from formalin-fixed paraffin-embedded tissue samples from patients with squamous cell carcinoma of the head and neck treated on clinical trial RTOG-9501.

OUTLINE: Formalin-fixed paraffin-embedded tissue samples are analyzed by DNA microarray analysis for gene expression profiling.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• microarray analysis
Assay RNA obtained from archived formalin fixed paraffin embedded tissue samples
Other:
• laboratory biomarker analysis
The gene expression data will be linked to the clinical information in order to generate profile of recurrence and survival as a biomarker.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis at time of surgical resection No
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