Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
Recruitment status was: Not yet recruiting
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.
Head and Neck Cancer
Genetic: gene expression analysis
Genetic: in situ hybridization
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Official Title:||Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)|
- Treatment response [ Designated as safety issue: No ]
- Survival endpoints (e.g., overall survival and progression-free survival) [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487733
|Principal Investigator:||Athanassios Argiris, MD||The University of Texas Health Science Center at San Antonio|