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Clinical Trials/NCT00898638
NCT00898638
Recruiting
Not Applicable

Head and Neck Tumor Tissue Repository and Clinical Database

Vanderbilt University Medical Center4 sites in 1 country8,000 target enrollmentFebruary 13, 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Vanderbilt University Medical Center
Enrollment
8000
Locations
4
Primary Endpoint
Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer
Status
Recruiting
Last Updated
6 months ago

Overview

Brief Summary

RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.

Detailed Description

OBJECTIVES: * Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer. * Develop a repository of biospecimens from these patients. OUTLINE: Tumor tissue samples and/or bronchial washings are collected from patients undergoing planned surgery and/or bronchoscopy, respectively. Buccal swabs and/or mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter. Healthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only. Information about medical and family history and cancer risk factors is also collected. PROJECTED ACCRUAL: No limit. FOLLOW UP: Indefinite, until date of death or lost to follow up.

Registry
clinicaltrials.gov
Start Date
February 13, 2003
End Date
December 1, 2050
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eben Rosenthal

Dept Chairperson Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer

Time Frame: ongoing

Collection of data for both groups from the Vanderbilt Otolaryngology Patient Intake questionnaire as well as the medical record, such as medical history, family history, and exposures to risk factors for cancer (tobacco and alcohol use), and results of tests related to diagnosis of tumor and treatment response (for tumor patients only).

Development of a repository of biospecimens

Time Frame: ongoing

Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.

Study Sites (4)

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