Skip to main content
OpenTrials
Completed

NCT Number: NCT02042105

A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong General Hospital, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer

    Time frame: one and half years

Secondary outcomes

  1. demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients

    Time frame: one and half years

Other outcomes

  1. prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.

    Time frame: one and half years

Sponsors and collaborators

Lead sponsor

Guangdong Association of Clinical Trials

Other

Registry information

Official study title

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

Acronym: C-TALK

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.