Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
|ClinicalTrials.gov Identifier: NCT01487733|
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Genetic: gene expression analysis Genetic: in situ hybridization Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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).
|Study Type :||Observational|
|Actual Enrollment :||155 participants|
|Official Title:||Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)|
|Actual Study Start Date :||December 22, 2011|
|Actual Primary Completion Date :||January 22, 2012|
|Actual Study Completion Date :||January 22, 2012|
- Treatment response [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487733
|Principal Investigator:||Athanassios Argiris, MD||The University of Texas Health Science Center at San Antonio|