Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899769
First received: May 9, 2009
Last updated: August 11, 2009
Last verified: October 2008
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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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Differences in serum protein profiles and differences in the number of peptide matches [ Designated as safety issue: No ]
- Protein levels and the largest difference in peptide matches in sera [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2005 |
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 and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899769
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Wendell G Yarbrough 615-343-8840 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Wendell G Yarbrough 615-343-8840 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | Wendell G. Yarbrough, MD, FACS | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00899769 History of Changes |
| Other Study ID Numbers: | CDR0000546781, VU-VICC-HN-0530, VU-VICC-IRB-050230 |
| Study First Received: | May 9, 2009 |
| Last Updated: | August 11, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 May 16, 2013