Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants

October 24, 2025 updated by: Eben Rosenthal, Vanderbilt University Medical Center

Head and Neck Tumor Tissue Repository and Clinical Database

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Clinical Trials Office - Vanderbilt-Ingram Cancer Center
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37064
        • Recruiting
        • Vanderbilt-Ingram Cancer Center - Cool Springs
        • Contact:
          • Eben Rosenthal, MD
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37064
        • Recruiting
        • Vanderbilt-Ingram Cancer Center at Franklin
        • Contact:
          • Eben Rosenthal, MD
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Veterans Affairs Medical Center - Nashville
        • Contact:
          • Clinical Trials Office - Veterans Affairs Medical Center - Nas
          • Phone Number: 615-327-4751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Head and neck tumor patients, aged 18 and older and Healthy volunteers, aged 18 and older.

Description

DISEASE CHARACTERISTICS:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: biologic sample preservation procedure
Other: 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.).
Other: biologic sample preservation procedure
Other: medical chart review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
ongoing
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.
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Eben Rosenthal, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2003

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000546682
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-HN-0356
  • VU-VICC-IRB-030062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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