We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898664
First Posted: May 12, 2009
Last Update Posted: April 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
  Purpose

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.


Condition Intervention
Head and Neck Cancer Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genetic Analysis of Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Assess common genetic mutations in tumor and germline DNA samples [ Time Frame: Upon collection of final patient data ]
  • Viral DNAs related to demographics, tumor characteristics, and patient prognosis [ Time Frame: 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 ]
  • Tumor suppressor gene mutations related to gene expression data [ Time Frame: 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 ]

Biospecimen Retention:   Samples With DNA
Assess common genetic mutations in tumor and germline DNAs from HNSCCs and search for viral DNAs and relate this information to demographics, tumor characteristics and patient prognosis.

Enrollment: 74
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: cytogenetic analysis
    not specified
    Genetic: gene expression analysis
    Not specified
    Genetic: mutation analysis
    Not specified
    Genetic: polymerase chain reaction
    not specified
    Other: immunohistochemistry staining method
    not specified
    Other: laboratory biomarker analysis
    not specified
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Nonsmoking patients less than 40 years of age at first diagnosis of HNSCC.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898664


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

Responsible Party: Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898664     History of Changes
Other Study ID Numbers: VICC HN 0625
VU-VICC-HN-0625
VU-VICC-IRB-060462
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: April 2, 2013
Last Verified: March 2013

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site