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

Head and Neck Cancer Clinical Trial

Official title:

Head and Neck Tumor Tissue Repository and Clinical Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00898638
• Other study ID #: CDR0000546682
• Secondary ID: P30CA068485VU-VI
• Status: Recruiting
• Start date: February 13, 2003
• Est. completion date: December 2050

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: Brandee Brown
• Phone: 615-936-4896
• Email: brandee.t.brown[@]vumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• biologic sample preservation procedure

• medical chart review

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer	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
Primary	Development of a repository of biospecimens	Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.	ongoing