Clinical trial NCT00899769: Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers
Official title: Serum Biomarkers for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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 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

Primary outcomes:
measure: Differences in serum protein profiles and differences in the number of peptide matches
measure: Protein levels and the largest difference in peptide matches in sera
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Wendell G. Yarbrough, MD, FACS
role: STUDY_CHAIR
References: