A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

Completed

• Conditions: Non-small-cell Lung Cancer

• Registration Number: NCT02042105
• Lead Sponsor: Guangdong Association of Clinical Trials

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 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.

Study Timeline

• Study First Submitted: 2013-11-09
• Study Start: 2013-11-11
• Study First Submitted QC: 2014-01-19
• Study First Posted: 2014-01-22
• Primary Completion: 2015-04-15
• Study Completion: 2016-07-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3649

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer	one and half years

Secondary Outcome Measures

Name	Time	Method
demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients	one and half years

Trial Locations

Locations (2)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China