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

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Other: biologic sample preservation procedure; Other: medical chart review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898638

P30CA068485 (U.S. NIH Grant/Contract)

CDR0000546682

VU-VICC-IRB-030062

VU-VICC-HN-0356

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

8,000 participants in 2 patient groups

Healthy Volunteers

Description:

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.

Treatment:

Other: medical chart review

Other: biologic sample preservation procedure

Head and Neck Tumor patients

Description:

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.).

Treatment:

Other: medical chart review

Other: biologic sample preservation procedure