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

This study is currently recruiting participants.
Verified June 2017 by Young Jun Kim, Vanderbilt University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898638
First Posted: May 12, 2009
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Young Jun Kim, Vanderbilt University Medical Center
  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

Resource links provided by NLM:


Further study details as provided by Young Jun Kim, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898638


Contacts
Contact: Michelle Pham, BS 615-936-4896 michelle.pham@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

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 Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: June 2, 2017
Last Verified: June 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