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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	8000 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Target Follow-Up Duration:	9999 Days
Official Title:	Head and Neck Tumor Tissue Repository and Clinical Database
Actual Study Start Date :	February 13, 2003
Estimated Primary Completion Date :	December 2050
Estimated Study Completion Date :	December 2050

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).
2. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Head and neck tumor patients, aged 18 and older and Healthy volunteers, aged 18 and older.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Brandee Brown	615-936-4896	brandee.t.brown@vanderbilt.edu

Locations

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

Sponsors and Collaborators

Vanderbilt University Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Young Kim, MD	Vanderbilt-Ingram Cancer Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	May 12, 2009
Last Update Posted:	January 25, 2018
Last Verified:	January 2018
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