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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897052
First received: May 9, 2009
Last updated: September 7, 2012
Last verified: September 2012

May 9, 2009
September 7, 2012
February 2005
December 2007   (final data collection date for primary outcome measure)
Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis [ Time Frame: at time of surgical resection ] [ Designated as safety issue: No ]
Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897052 on ClinicalTrials.gov Archive Site
Not Provided
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Gene Expression Profiles in Predicting Survival of Patients With Head and Neck Cancer
Survival Prediction in HNSCC Based on Gene Expression Profiles From FFPE Tissues

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Prior patients who participated on clinical trial RTOG-9501

Head and Neck Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00897052
VICC HN 0511, VU-VICC-HN-0511, VU-VICC-IRB-040509
Yes
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP