NCT00899769

Brief Summary

RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4.1 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

March 14, 2017

Status Verified

March 1, 2017

First QC Date

May 9, 2009

Last Update Submit

March 10, 2017

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Differences in serum protein profiles and differences in the number of peptide matches

  • Protein levels and the largest difference in peptide matches in sera

Interventions

protein expression analysisGENETIC
proteomic profilingGENETIC
immunoenzyme techniqueOTHER
laboratory biomarker analysisOTHER
liquid chromatographyOTHER
mass spectrometryOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Diagnosis of squamous cell carcinoma of the head and neck * Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

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

Interventions

Immunoenzyme TechniquesChromatography, LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe TechniquesChromatographyChemistry Techniques, Analytical

Study Officials

  • Wendell G. Yarbrough, MD, FACS

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2005

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(3)