A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

Overview

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.

Full Title of Study: “A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer (NSCLC) Patients With ALK Positive in China”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 15, 2015

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients
    • Time Frame: one and half years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Association of Clinical Trials
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yi-Long Wu, MD, Principal Investigator, Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
    • Yi-Long Wu, MD, Principal Investigator, Guangdong Provincial People’s Hospital

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