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CompletedNCT00899769Updated Mar 14, 2017

Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers

An observational study in Head and Neck Cancer, sponsored by Vanderbilt University Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Enrollment
100
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.
  • Correlate protein levels with the largest difference in peptide matches in sera in these participants.

OUTLINE: This is a prospective study.

Participants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.

PROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage I squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the nasopharynx
  • stage I 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 hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent salivary gland cancer
  • 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
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Enrollment
100 participants (estimated)

Interventions

  • Geneticprotein expression analysis
  • Geneticproteomic profiling
  • Otherimmunoenzyme technique
  • Otherlaboratory biomarker analysis
  • Otherliquid chromatography
  • Othermass spectrometry
06

What researchers measure

Primary outcomes

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

  2. Protein levels and the largest difference in peptide matches in sera

07

Study locations

3 sites
  • Vanderbilt-Ingram Cancer Center - Cool Springs
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center at Franklin
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00899769
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Apr 2005
Last update
Mar 14, 2017

Study contacts

Wendell G. Yarbrough, MD, FACS
study chair · Vanderbilt-Ingram Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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