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ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT02946216
Recruitment Status : Unknown
Verified October 2016 by First People's Hospital of Hangzhou.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
First People's Hospital of Hangzhou

Tracking Information
First Submitted Date October 25, 2016
First Posted Date October 27, 2016
Last Update Posted Date October 27, 2016
Study Start Date November 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2016)
  • Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) [ Time Frame: up to 2 years ]
    The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC)
  • Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance [ Time Frame: up to 2 years ]
    The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC) after crizotinib resistance
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Non-small cell lung cancer (NSCLC)
Condition
  • Non-small Cell Lung Cancer Stage III
  • Non-Small-Cell Lung Cancer Metastatic
  • Adenocarcinoma of Lung
  • EGFR Wildtype
Intervention Genetic: ctDNA analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 25, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02946216
Other Study ID Numbers 2016-101-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party First People's Hospital of Hangzhou
Study Sponsor First People's Hospital of Hangzhou
Collaborators Not Provided
Investigators Not Provided
PRS Account First People's Hospital of Hangzhou
Verification Date October 2016