Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors predict how well patients will respond to treatment.

      PURPOSE: This research study is studying biomarkers in tissue samples from patients with
      recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.
    

Detailed description: 
      OBJECTIVES:

        -  To investigate the association between biomarkers (HPV tumor status and ERCC1
           expression) and clinical outcomes in a population of patients with recurrent or
           metastatic head and neck cancer.

        -  To develop the ability to select patients likely to respond to therapy and to avoid
           treatment with ineffective therapies, especially since these therapies have substantial
           toxicity.

        -  To estimate response and survival rates of HPV-negative and -positive patients in each
           study. (exploratory)

      OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also
      undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC
      analysis.

      Samples are classified into two categories based on their biomarker status: HPV tumor status
      (negative versus positive), and ERCC1 expression level (low versus high).
    

Intervention name(s): gene expression analysis; in situ hybridization; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients who participated in E1395 or E3301 and provided samples for research.
      
Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma; metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; salivary gland squamous cell carcinoma; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IVA squamous cell carcinoma of the larynx; stage IVA squamous cell carcinoma of the lip and oral cavity; stage IVA squamous cell carcinoma of the oropharynx; stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVB squamous cell carcinoma of the larynx; stage IVB squamous cell carcinoma of the lip and oral cavity; stage IVB squamous cell carcinoma of the oropharynx; stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVC squamous cell carcinoma of the larynx; stage IVC squamous cell carcinoma of the lip and oral cavity; stage IVC squamous cell carcinoma of the oropharynx; stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; stage III salivary gland cancer; stage IVA salivary gland cancer; stage IVB salivary gland cancer; stage IVC salivary gland cancer