A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors
NCT ID: NCT03424980
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-12-31
2018-04-30
Brief Summary
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Detailed Description
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The effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. The safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. The mutation status of epidermal growth factor receptor (EGFR) and the type of anaplastic lymphoma kinase (ALK) will be assessed. All the study procedures will be in compliance with International Clinical Harmonization - Good Clinical Practice (ICH-GCP), standard operation procedures (SOPs), and regulatory policies/regulations.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Tyrosine kinase inhibitors
Diagnosed patients with advanced non-small cell lung cancer (NSCLC) with brain metastases who were administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors
Tyrosine kinase inhibitors
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
Interventions
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Tyrosine kinase inhibitors
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
Eligibility Criteria
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Inclusion Criteria
* The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);
* The patients who are observed with brain metastases diagnosed by imaging methods;
* The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;
* The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;
ALL
No
Sponsors
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LinkDoc Technology (Beijing) Co. Ltd.
INDUSTRY
Tang-Du Hospital
OTHER
Responsible Party
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Zhang Helong
Professor
Principal Investigators
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Helong Zhang
Role: PRINCIPAL_INVESTIGATOR
Xi'an Tangdu Hospital
Locations
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China PLA General Hospital
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W-TONG03
Identifier Type: -
Identifier Source: org_study_id
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