Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
NCT ID: NCT00898638
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
8000 participants
OBSERVATIONAL
2003-02-13
2050-12-31
Brief Summary
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PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy Volunteers
Non-tumor volunteers will be asked to participate at the time that they are attending a head and neck cancer screening clinic or at the time they are accompanying a patient to their appointment at the head and neck clinic. Intake sheets and biological specimens contributed by volunteers will be coded at the time of collection so that no identifiers are obtained. These specimens will not be linked to identifiers.
biologic sample preservation procedure
medical chart review
Head and Neck Tumor patients
Eligible patients will be identified at the Vanderbilt Head \& Neck Clinic by clinical and research staff. An appropriately trained staff member will discuss the protocol with the patient (including, risks, benefits, alternatives, etc.).
biologic sample preservation procedure
medical chart review
Interventions
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biologic sample preservation procedure
medical chart review
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Diagnosis of head and neck cancer
* Being treated at Vanderbilt University Medical Center for the cancer
* Healthy participant
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Eben Rosenthal
Dept Chairperson Professor
Principal Investigators
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Eben Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Eben Rosenthal, MD
Role: primary
Eben Rosenthal, MD
Role: primary
Clinical Trials Office - Veterans Affairs Medical Center - Nas
Role: primary
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Role: primary
Other Identifiers
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VU-VICC-HN-0356
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-030062
Identifier Type: -
Identifier Source: secondary_id
CDR0000546682
Identifier Type: -
Identifier Source: org_study_id
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