Clinical Trials /

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

NCT00898638

Description:

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.

Related Conditions:
  • Head and Neck Carcinoma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
  • Official Title: Head and Neck Tumor Tissue Repository and Clinical Database

Clinical Trial IDs

  • ORG STUDY ID: CDR0000546682
  • SECONDARY ID: P30CA068485
  • SECONDARY ID: VU-VICC-HN-0356
  • SECONDARY ID: VU-VICC-IRB-030062
  • NCT ID: NCT00898638

Conditions

  • Head and Neck Cancer

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Healthy VolunteersNon-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 patientsEligible 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.).

      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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:Accepts Healthy Volunteers

      Primary Outcome Measures

      Measure:Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer
      Time Frame:ongoing
      Safety Issue:
      Description: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).

      Details

      Phase:N/A
      Primary Purpose:Observational [Patient Registry]
      Overall Status:Recruiting
      Lead Sponsor:Vanderbilt University Medical Center

      Trial Keywords

      • 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 adenoid cystic carcinoma of the oral cavity
      • 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 adenoid cystic 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 adenoid cystic carcinoma of the oral cavity
      • stage III basal cell carcinoma of the lip
      • stage III mucoepidermoid carcinoma of the oral cavity
      • stage III squamous cell carcinoma of the lip and oral cavity
      • stage III verrucous carcinoma of the oral cavity
      • stage IV adenoid cystic carcinoma of the oral cavity
      • stage IV basal cell carcinoma of the lip
      • stage IV mucoepidermoid carcinoma of the oral cavity
      • stage IV squamous cell carcinoma of the lip and oral cavity
      • stage IV verrucous carcinoma of the oral cavity
      • recurrent adenoid cystic carcinoma of the oral cavity
      • recurrent basal cell carcinoma of the lip
      • recurrent mucoepidermoid carcinoma of the oral cavity
      • recurrent squamous cell carcinoma of the lip and oral cavity
      • recurrent verrucous carcinoma of the oral cavity
      • metastatic squamous neck cancer with occult primary squamous cell carcinoma
      • recurrent metastatic squamous neck cancer with occult primary
      • untreated metastatic squamous neck cancer with occult primary
      • stage I lymphoepithelioma of the nasopharynx
      • stage I squamous cell carcinoma of the nasopharynx
      • stage II lymphoepithelioma of the nasopharynx
      • stage II squamous cell carcinoma of the nasopharynx
      • stage III lymphoepithelioma of the nasopharynx
      • stage III squamous cell carcinoma of the nasopharynx
      • stage IV lymphoepithelioma of the nasopharynx
      • stage IV squamous cell carcinoma of the nasopharynx
      • recurrent lymphoepithelioma of the nasopharynx
      • recurrent squamous cell carcinoma of the nasopharynx
      • stage I lymphoepithelioma of the oropharynx
      • stage I squamous cell carcinoma of the oropharynx
      • stage II lymphoepithelioma of the oropharynx
      • stage II squamous cell carcinoma of the oropharynx
      • stage III lymphoepithelioma of the oropharynx
      • stage III squamous cell carcinoma of the oropharynx
      • stage IV lymphoepithelioma of the oropharynx
      • stage IV squamous cell carcinoma of the oropharynx
      • recurrent lymphoepithelioma of the oropharynx
      • stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
      • stage I inverted papilloma of the paranasal sinus and nasal cavity
      • stage I midline lethal granuloma of the paranasal sinus and nasal cavity
      • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
      • stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
      • stage II inverted papilloma of the paranasal sinus and nasal cavity
      • stage II midline lethal granuloma of the paranasal sinus and nasal cavity
      • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
      • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
      • stage III inverted papilloma of the paranasal sinus and nasal cavity
      • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
      • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
      • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
      • stage IV inverted papilloma of the paranasal sinus and nasal cavity
      • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
      • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
      • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
      • recurrent inverted papilloma of the paranasal sinus and nasal cavity
      • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
      • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
      • stage I salivary gland cancer
      • stage II salivary gland cancer
      • stage III salivary gland cancer
      • stage IV salivary gland cancer
      • recurrent salivary gland cancer
      • recurrent squamous cell carcinoma of the oropharynx

      Last Updated

      January 23, 2018