Brief Title
ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC
Official Title
Frequency and Abundance of ALK/ROS1/MET Mutations on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer Using Single Molecule Amplifcation and Re-sequencing Technology: a Perspective Observational Study
Brief Summary
The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA
samples in EGFR-wildtype NSCLC
Study Type
Observational
Primary Outcome
Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART)
Condition
Non-small Cell Lung Cancer Stage III
Intervention
ctDNA analysis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
200
Start Date
November 2016
Completion Date
November 2018
Primary Completion Date
November 2017
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed stage IIIB/IV NSCLC;
- Histologically confirmed adenocarcinoma;
- EGFR-wildtype NSCLC;
- Provision of blood (plasma) sample for ctDNA testing;
- Patient must be able to comply with the protocol;
- Provision of blood (plasma) sample for ctDNA testing;
Exclusion Criteria:
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease
(e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
- Histologically confirmed small cell lung cancer or other metastatic tumors;
- Patient with no histologic or cytological diagnosis;
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 057156007908, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02946216
Organization ID
2016-101-01
Responsible Party
Sponsor
Study Sponsor
First People's Hospital of Hangzhou
Study Sponsor
, ,
Verification Date
October 2016