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Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
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Purpose
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 | Intervention |
|---|---|
| Head and Neck Cancer | Other: biologic sample preservation procedure Other: medical chart review |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Target Follow-Up Duration: | 9999 Days |
| Official Title: | Head and Neck Tumor Tissue Repository and Clinical Database |
- Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer [ Time Frame: 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 [ Time Frame: ongoing ]Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.
Biospecimen Retention: Samples With DNA
Retrospective --Pathology archives will be reviewed and those with a sufficient amount of formalin-fixed tumor may be enrolled. Additionally, normal tissue from upper aerodigestive tract tissue excised for benign conditions will be collected. A one-time collection of medical data will be done for these cases. Specimens and datasets may also be incorporated from other studies with specimens and/or useful data left over.
Prospective -- For non-tumor volunteers: After patient has signed consent, mouth cells and/or saliva samples will be obtained. If the patient agrees to having a biopsy, tissue may also be collected.
For tumor patients: If the patient requires surgery, biological specimens will be collected day of surgery. The pathologist or designated lab personnel will oversee processing of the specimens. If the patient is scheduled to have a bronchoscopy, a bronchial washing may be collected.
| Estimated Enrollment: | 8000 |
| Actual Study Start Date: | February 13, 2003 |
| Estimated Study Completion Date: | December 2050 |
| Estimated Primary Completion Date: | December 2050 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00898638
| Contact: Michelle Pham, BS | 615-936-4896 | michelle.pham@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Kim Young 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Kim Young, MD 800-811-8480 | |
| Veterans Affairs Medical Center - Nashville | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas 615-327-4751 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Principal Investigator: | Young Kim, MD | Vanderbilt-Ingram Cancer Center |
More Information
| Responsible Party: | Young Jun Kim, Associate Professor, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00898638 History of Changes |
| Other Study ID Numbers: |
CDR0000546682 P30CA068485 ( U.S. NIH Grant/Contract ) VU-VICC-HN-0356 VU-VICC-IRB-030062 |
| Study First Received: | May 9, 2009 |
| Last Updated: | June 1, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Young Jun Kim, Vanderbilt University Medical Center:
|
stage I adenoid cystic carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent adenoid cystic carcinoma of the oral cavity stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx |
stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage I basal cell carcinoma of the lip stage I mucoepidermoid carcinoma of the oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage I verrucous carcinoma of the oral cavity stage II basal cell carcinoma of the lip stage II mucoepidermoid carcinoma of the oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage II verrucous carcinoma of the oral cavity stage III basal cell carcinoma of the lip stage III mucoepidermoid carcinoma of the oral cavity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on August 18, 2017