A Prospective Epidemiologic Study of ALK-Positive NSCLC in China
C-TALK
A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer (NSCLC) Patients With ALK Positive in China
1 other identifier
observational
3,649
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2013
CompletedStudy Start
First participant enrolled
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2016
CompletedMarch 1, 2017
February 1, 2017
1.4 years
November 9, 2013
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer
one and half years
Secondary Outcomes (1)
demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients
one and half years
Other Outcomes (1)
prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.
one and half years
Eligibility Criteria
unselected Chinese patients with non-small-cell lung cancer
You may qualify if:
- Adult patients (≥18 years), both sex.
- Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.
- Written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Long Wu, MD
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Yi-Long Wu, MD
Guangdong Provincial People's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2013
First Posted
January 22, 2014
Study Start
November 11, 2013
Primary Completion
April 15, 2015
Study Completion
July 6, 2016
Last Updated
March 1, 2017
Record last verified: 2017-02