Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02042105
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2013-11-09
Brief Title:
A Prospective Epidemiologic Study of ALK-Positive NSCLC in China
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Guangdong Association of Clinical Trials
Study Overview
Official Title:
A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer NSCLC Patients With ALK Positive in China
Status:
COMPLETED
Status Verified Date:
2017-02
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:
C-TALK
Brief Summary:
This is a post-marketing observational non-interventional multi-central study of patients with non-small cell lung cancer NSCLC with data collected prospectively from medical records at inclusion The primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase ALK-positive in unselected Chinese patients with NSCLC
Detailed Description:
Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology ALK positive status will be detected by Ventana immunohistochemistry IHC Ventana Medical Systems Inc and Roche Diagnostics International Inc When ALK positive patients are detected crizotinib will be administrated by various solutions based on physicians desecration and patients willingness
The secondary objectives include 1To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC2To describe demographic socioeconomic such as age gender raceethnicity geographic location including ruralurban area pathologic parameters education family income National Reimbursement Drug List NRDL or Provincial Reimbursement List PRDL and clinical characteristics of NSCLC patients with ALK positive
The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally
The secondary objectives include 1To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC2To describe demographic socioeconomic such as age gender raceethnicity geographic location including ruralurban area pathologic parameters education family income National Reimbursement Drug List NRDL or Provincial Reimbursement List PRDL and clinical characteristics of NSCLC patients with ALK positive
The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None