NCT00898664

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

May 9, 2009

Last Update Submit

March 29, 2013

Conditions

Keywords

stage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitymetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primarystage I squamous cell carcinoma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitysalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancer

Outcome Measures

Primary Outcomes (5)

  • Assess common genetic mutations in tumor and germline DNA samples

    Upon collection of final patient data

  • Viral DNAs related to demographics, tumor characteristics, and patient prognosis

    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

    Upon collection of final patient data

  • Tumor suppressor gene mutations related to gene expression 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

    upon collection of final patient data

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

Cytogenetic AnalysisGene Expression ProfilingPolymerase Chain ReactionImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesNucleic Acid Amplification TechniquesHistocytochemistryHistological TechniquesImmunologic Techniques

Study Officials

  • Barbara Murphy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Medical Oncologist

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 2, 2013

Record last verified: 2013-03