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NCT00899769 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Serum Biomarkers for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00899769
Other study ID # CDR0000546781
Secondary ID P30CA068485VU-VI
Status Completed
Phase N/A
First received May 9, 2009
Last updated March 10, 2017
Start date April 2005

Study information
Verified date March 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• protein expression analysis

• proteomic profiling

Other:
• immunoenzyme technique

• laboratory biomarker analysis

• liquid chromatography

• mass spectrometry

Locations
Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center at Franklin Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in serum protein profiles and differences in the number of peptide matches
Primary Protein levels and the largest difference in peptide matches in sera
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