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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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.


Condition Intervention
Head and Neck Cancer
 Genetic: microarray analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survival Prediction in HNSCC Based on Gene Expression Profiles From FFPE Tissues

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 29
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prior patients who participated on clinical trial RTOG-9501

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897052

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897052     History of Changes
Other Study ID Numbers: VICC HN 0511, VU-VICC-HN-0511, VU-VICC-IRB-040509
Study First Received: May 9, 2009
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013