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

NCT ID: NCT00898638

Last Updated: 2025-10-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-13

Study Completion Date

2050-12-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

medical chart review

Intervention Type OTHER

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

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Interventions

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biologic sample preservation procedure

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eben Rosenthal

Dept Chairperson Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status RECRUITING

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brandee Brown

Role: CONTACT

615-936-4896

Facility Contacts

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Eben Rosenthal, MD

Role: primary

800-811-8480

Eben Rosenthal, MD

Role: primary

800-811-8480

Clinical Trials Office - Veterans Affairs Medical Center - Nas

Role: primary

615-327-4751

Clinical Trials Office - Vanderbilt-Ingram Cancer Center

Role: primary

800-811-8480

Other Identifiers

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P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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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