A Prospective Epidemiologic Study of ALK-Positive NSCLC in China
Non-small-cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non-small-cell lung cancer, anaplastic lymphoma kinase, immunohistochemistry
Study Type
Study Phase
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
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 physician's desecration and patients' willingness.

The secondary objectives include: 1.To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC.2.To describe demographic, socioeconomic [such as age, gender, race/ethnicity, geographic location (including rural/urban 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients (≥18 years), both sex.

- Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.

- Written informed consent.

Exclusion Criteria:

- Those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (SCLC) or metastatic disease from other organs.
Guangdong General Hospital
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jin-Ji Yang, MD - 86 20 83827812 - yangjinji2003@163.com
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jin-Ji Yang, MD - +86 20 83827812 - yangjinji2003@163.com
Start Date
November 2013
Completion Date
July 2015
Guangdong Association of Clinical Trials
Guangdong Association of Clinical Trials
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page