Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 3:23 AM
Study NCT ID:
NCT01466257
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2011-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With Head and Neck Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.
Detailed Description:
OBJECTIVES:
* 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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECOG-E5397T2 | None | None | View |