Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301

Study Overview
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Brief Summary
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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
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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).

Official Title
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Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: in situ hybridization
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301 Stage III, IV, or recurrent disease Squamous cell disease Any of the following diagnoses: Lip and oral cavity Oropharynx Hypopharynx Larynx Paranasal sinus and nasal cavity Squamous neck cancer Salivary gland PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: in situ hybridization|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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