- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418234
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
February 12, 2018 updated by: First People's Hospital of Hangzhou
Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure
Study Type
Observational
Enrollment (Actual)
314
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- Hangzhou First People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure
Description
Inclusion Criteria:
- Histologically confirmed stage IIIB/IV NSCLC.
- Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
- Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- Patient must be able to comply with the protocol
Exclusion Criteria:
- Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
- Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- Histologically confirmed small cell lung cancer or other metastatic tumors
- Patient with no histologic or cytological diagnosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
Time Frame: up to 2 years
|
The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).
|
up to 2 years
|
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
Time Frame: up to 2 years
|
The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure
Time Frame: up to 2 years
|
The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.
|
up to 2 years
|
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure
Time Frame: up to 2 years
|
The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
April 3, 2015
First Submitted That Met QC Criteria
April 13, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Actual)
March 12, 2018
Last Update Submitted That Met QC Criteria
February 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HZFH CA15-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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