Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy

Not Applicable

Recruiting

• Conditions: on-small cell lung cancer harboring driver mutation.

• Registration Number: JPRN-UMIN000017581
• Lead Sponsor: ational Cancer Center Hospital

Brief Summary

Methods: 33 cfDNA samples from patients who received EGFR-TKI therapy for tumor with sensitive mutations were subjected to a pdPCR-based examination of the proportion of sensitive mutant cfDNAs with the T790M mutation. Results: sensitive mutations were detected in all 8 samples obtained after acquisition of resistance to TKIs and T790M mutation were positive in 5 of the samples. Conclusions: pdPCR-based examination of cfDNAs represents a robust non-invasive assessment of tumor progression status.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Results First Posted: 2016-01-14
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient who need other anti-malignant medicine, radiotherapy or immunity. 2)Patient with positive HBs antigen and HBV-DNA. 3)Patient with definite positive HIV antibody (need not for examination). 4)Patient with other active cancer (except cancer treated without recurrence in more than 5 years and after carcinoma complete excision in situ) 5)TPatient with interstitial pneumonia 6)Any other patients who are regarded as unsuitable for this study by the investigators.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the quantitative analysis using of EGFR mutation sensitive mutation and T790M mutation in the cfDNA of NSCLC patients who were treated with the conventional EGFR-TKI. To evaluate the quantitative analysis using of driver mutation (i.e. ALK/RET/ROS1 fusion)and resistant mutation in the cfDNA of NSCLC patients who were treated with the TKIs.

Secondary Outcome Measures

Name	Time	Method
To evaluate treatment benefit and acquiring resistance from change of fraction of sensitivity mutation and resistant mutation. To evaluate the concordance between the amount of cfDNA and clinical course.