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Recruiting NCT00898638

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

Observational Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biologic sample preservation procedure, medical chart review.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Head and Neck Tumor Tissue Repository and Clinical Database

Overview

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.

Interventions

  • Other biologic sample preservation procedure
  • Other medical chart review

Primary outcome measures

  • Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer [Time frame: ongoing]
  • Development of a repository of biospecimens [Time frame: ongoing]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville
  • Vanderbilt-Ingram Cancer Center at Franklin — Nashville
  • Veterans Affairs Medical Center - Nashville — Nashville
  • Vanderbilt-Ingram Cancer Center — Nashville

Identifiers

NCT: NCT00898638 · CDR0000546682 · P30CA068485 · VU-VICC-HN-0356 · VU-VICC-IRB-030062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗