Tissue Sample Collection from Patients with Head and Neck Cancer and from Healthy Participants
- Conditions
- Head and Neck Cancer
- Interventions
- Other: biologic sample preservation procedureOther: medical chart review
- Registration Number
- NCT00898638
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Volunteers biologic sample preservation procedure 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. Healthy Volunteers medical chart review 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. Head and Neck Tumor patients biologic sample preservation procedure 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.). Head and Neck Tumor patients medical chart review 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.).
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Nashville
🇺🇸Nashville, Tennessee, United States