Clinical trial NCT00898664: DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer
Official title: Genetic Analysis of Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
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
recurrent squamous cell carcinoma of the lip and oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
untreated metastatic squamous neck cancer with occult primary
stage I squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nonsmoking patients less than 40 years of age at first diagnosis of HNSCC.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess common genetic mutations in tumor and germline DNA samples
timeFrame: Upon collection of final patient data
measure: Viral DNAs related to demographics, tumor characteristics, and patient prognosis
timeFrame: Upon collection of final patient data
measure: 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
timeFrame: Upon collection of final patient data
measure: Tumor suppressor gene mutations related to gene expression data
timeFrame: upon collection of final patient data
measure: Validation of gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry
timeFrame: upon collection of final patient data
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: STUDY_CHAIR
References: