DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer

March 29, 2013 updated by: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Genetic Analysis of Head and Neck Squamous Cell Carcinoma

RATIONALE: Studying samples of 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.

PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
  • Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
  • Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
  • Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
  • Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.

OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.

Study Type

Observational

Enrollment (Actual)

74

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Nonsmoking patients less than 40 years of age at first diagnosis of HNSCC.

Description

Inclusion Criteria:

  • Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository

    • Sufficient biological material collected to perform study tests
  • Historical material available from excess tissues at the Vanderbilt Pathology Department

Exclusion Criteria:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess common genetic mutations in tumor and germline DNA samples
Time Frame: Upon collection of final patient data
Upon collection of final patient data
Viral DNAs related to demographics, tumor characteristics, and patient prognosis
Time Frame: Upon collection of final patient data
Upon collection of final patient data
Novel viral sequences and cancer-associated gene mutations in young nonsmoking patients with head and neck squamous cell carcinoma and in other distinct head and neck cancers
Time Frame: Upon collection of final patient data
Upon collection of final patient data
Tumor suppressor gene mutations related to gene expression data
Time Frame: upon collection of final patient data
upon collection of final patient data
Validation of gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry
Time Frame: upon collection of final patient data
upon collection of final patient data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 29, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC HN 0625
  • VU-VICC-HN-0625
  • VU-VICC-IRB-060462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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