Biomarkers in Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01466257|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : May 19, 2017
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Biological: cetuximab Drug: cisplatin Genetic: DNA analysis Genetic: gene expression analysis Genetic: mutation analysis Other: laboratory biomarker analysis|
- To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
- To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.
OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||November 21, 2011|
|Actual Primary Completion Date :||January 1, 2012|
|Actual Study Completion Date :||January 1, 2012|
- Mutation rates of HRAS and PIK3CA [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466257
|Principal Investigator:||Christine H. Chung, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|