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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00898638

Collaborator

National Cancer Institute (NCI) (NIH)

8,000

Enrollment

Locations

573.6

Anticipated Duration (Months)

2000

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: biologic sample preservation procedure Other: medical chart review

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

8000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Head and Neck Tumor Tissue Repository and Clinical Database

Actual Study Start Date :

Feb 13, 2003

Anticipated Primary Completion Date :

Dec 1, 2050

Anticipated Study Completion Date :

Dec 1, 2050

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer [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 [ongoing]
Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838