Tissue Sample Collection from Patients with Head and Neck Cancer and from Healthy Participants

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00898638
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vanderbilt University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Eben Rosenthal, MD
Principal Investigator Affiliation Vanderbilt University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Head and Neck Cancer
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.).

Interventions

Other: - biologic sample preservation procedure

Other: - medical chart review

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville 4644585, Tennessee 4662168, 37064

Site Contact

Eben Rosenthal, MD

[email protected]

800-811-8480

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center at Franklin

Nashville 4644585, Tennessee 4662168, 37064

Site Contact

Eben Rosenthal, MD

[email protected]

800-811-8480

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Veterans Affairs Medical Center - Nashville

Nashville 4644585, Tennessee 4662168, 37212

Site Contact

Clinical Trials Office - Veterans Affairs Medical Center - Nas

[email protected]

615-327-4751

Vanderbilt-Ingram Cancer Center, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center

Nashville 4644585, Tennessee 4662168, 37232-6838

Site Contact

Clinical Trials Office - Vanderbilt-Ingram Cancer Center

[email protected]

800-811-8480

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