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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00899769
First received: May 9, 2009
Last updated: March 10, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Head and Neck Cancer Genetic: protein expression analysis Genetic: proteomic profiling Other: immunoenzyme technique Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry

Study Type: Observational
Official Title: Serum Biomarkers for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Differences in serum protein profiles and differences in the number of peptide matches
  • Protein levels and the largest difference in peptide matches in sera

Estimated Enrollment: 100
Study Start Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899769

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Wendell G. Yarbrough, MD, FACS Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00899769     History of Changes
Other Study ID Numbers: CDR0000546781
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-HN-0530
VU-VICC-IRB-050230
Study First Received: May 9, 2009
Last Updated: March 10, 2017

Keywords provided by Vanderbilt University Medical Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2017