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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Locations

United States

Study Type

Observational

Intervention

protein expression analysis

proteomic profiling

immunoenzyme technique

laboratory biomarker analysis

liquid chromatography

mass spectrometry

About this trial

This is an observational trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vanderbilt-Ingram Cancer Center - Cool Springs
Vanderbilt-Ingram Cancer Center at Franklin
Vanderbilt-Ingram Cancer Center

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00899769

First Posted

May 9, 2009

Last Updated

March 10, 2017

Sponsor

Vanderbilt University Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00899769

Brief Title

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

Official Title

Serum Biomarkers for Head and Neck Cancer

Study Type

Observational

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

protein expression analysis

Intervention Type

Genetic

Intervention Name(s)

proteomic profiling

Intervention Type

Other

Intervention Name(s)

immunoenzyme technique

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Other

Intervention Name(s)

liquid chromatography

Intervention Type

Other

Intervention Name(s)

mass spectrometry

Primary Outcome Measure Information:

Title

Differences in serum protein profiles and differences in the number of peptide matches

Title

Protein levels and the largest difference in peptide matches in sera

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendell G. Yarbrough, MD, FACS

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center - Cool Springs

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center at Franklin

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

12. IPD Sharing Statement

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

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