Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers
Official Title
Serum Biomarkers for Head and Neck Cancer
Acronym
Not provided
Organization
Vanderbilt University Medical CenterOTHER
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2005
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
May 9, 2009
First Submission Date that Met QC Criteria
May 9, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 10, 2017
Last Update Posted Date
Mar 14, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vanderbilt University Medical CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
100Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
protein expression analysis
Genetic
proteomic profiling
Genetic
immunoenzyme technique
Other
laboratory biomarker analysis
Other
liquid chromatography
Other
mass spectrometry
Other
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Differences in serum protein profiles and differences in the number of peptide matches
Protein levels and the largest difference in peptide matches in sera
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Wendell G. Yarbrough, MD, FACS
Vanderbilt-Ingram Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville
Tennessee
37064
United States
Vanderbilt-Ingram Cancer Center at Franklin
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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