A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

Non-small-cell Lung Cancer Clinical Trial

— C-TALK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042105
• Other study ID #: CTONG1303
• Status: Completed
• Phase: N/A
• First received: November 9, 2013
• Last updated: February 28, 2017
• Start date: November 11, 2013
• Est. completion date: July 6, 2016

Study information

• Verified date: February 2017
• Source: Guangdong Association of Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3649
• Est. completion date: July 6, 2016
• Est. primary completion date: April 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.		one and half years
Primary	the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer		one and half years
Secondary	demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients		one and half years