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

Head and Neck Cancer Clinical Trial

Official title:

Genetic Analysis of Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898664
• Other study ID #: VICC HN 0625
• Secondary ID: VU-VICC-HN-0625V
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 29, 2013
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Genetic:
• cytogenetic analysis
not specified
• gene expression analysis
Not specified
• mutation analysis
Not specified
• polymerase chain reaction
not specified

Other:
• immunohistochemistry staining method
not specified
• laboratory biomarker analysis
not specified

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	Assess common genetic mutations in tumor and germline DNA samples		Upon collection of final patient data	No
Primary	Viral DNAs related to demographics, tumor characteristics, and patient prognosis		Upon collection of final patient data	No
Primary	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		Upon collection of final patient data	No
Primary	Tumor suppressor gene mutations related to gene expression data		upon collection of final patient data	No
Primary	Validation of gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry		upon collection of final patient data	No