Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have
      been surgically removed, may improve the treatment of patients with cancers of the head and
      neck.

      PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically
      removed from patients with cancers of the head and neck can predict recurrence of the cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether molecular detection of p53 mutation in cancerous cells of
           histologically negative tumor margins can predict local recurrence in patients with
           squamous cell carcinoma of the upper aerodigestive tract.

        -  Determine the incidence of p53 mutation in this population and its correlation with
           clinical parameters.

        -  Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1
           neck dissections can predict survival and the risks of regional recurrence and distant
           metastases in these patients.

      OUTLINE: This is a multicenter study.

      Patients undergo standard curative resection and neck node dissection (if appropriate).
      Specimens are collected from tumor tissue (necrosis-free, if possible), each wound quadrant,
      any neck disease with clinically negative nodes, and any neck disease with a single positive
      node for histologic and molecular analysis. Tissue and cells are examined for p53 mutation
      and DNA microsatellite repeat alterations. Patients undergo adjuvant radiotherapy and/or
      chemotherapy, as appropriate for clinical staging and histopathology, at the discretion of
      the participating clinician.

      Patients do not receive results of genetic testing and the results do not affect treatment.

      Patients are followed every 6 months for 3 years and then annually thereafter.

      PROJECTED ACCRUAL: A total 530 patients will be accrued for this study within 3.5 years.
    

Intervention name(s): DNA stability analysis; microsatellite instability analysis; mutation analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Keywords: stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; 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 II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity