Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-02 @ 8:13 PM
Study NCT ID:
NCT02738593
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection Cell Free DNA in Lung Cancer Patients
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Using Next Generation Sequencing (NGS) Method to Detect Circulating Free DNA (Cf-DNA) and Explore the Resistance and Prognosic Mechanism of Third Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine-kinase Inhibitor (TKI) in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: a Single Center Study
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc.
By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Detailed Description:
Study backgroud: third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is the newest target therapy for non small cell lung cancer (NSCLC). Two major study published in NEJM show that the overall response rate is about 60%-70%, with a progression free survival about 10 months. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.
Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc. By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Eligible patients received 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled into this study. Tumor tissue sample within 6 months, and 10ml periphereal blood samples were collected at baseline. After treatment initiation, 10ml periphereal blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centerfuged within 2 hours and store in -80 refrigerator.
NGS testing will cover target genes of NSCLC.
Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc. By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Eligible patients received 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled into this study. Tumor tissue sample within 6 months, and 10ml periphereal blood samples were collected at baseline. After treatment initiation, 10ml periphereal blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centerfuged within 2 hours and store in -80 refrigerator.
NGS testing will cover target genes of NSCLC.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: