A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042105

Acronym

C-TALK

Enrollment

3649

Registered

2014-01-22

Start date

2013-11-11

Completion date

2016-07-06

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

Keywords

non-small-cell lung cancer, anaplastic lymphoma kinase, immunohistochemistry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.	one and half years

Countries

China

Outcome results