Analysis of Plasma Tumor DNA in Lung Cancer Patients

• Conditions: Non Small Cell Lung Cancer Patients

• Registration Number: NCT01930474
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in \<50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-29
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
• Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
• Patients must have given written informed consent

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Exclusion Criteria

• Patients who refuse the blood samplings

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of genetic alterations (including EGFR and ALK) in plasma samples	60 months	To evaluate the sensitivity of digital PCR to detect the genetic alterations in plasma tumor DNA

Secondary Outcome Measures

Name	Time	Method
Quantifying circulating tumor DNA in serially collected plasma specimens	60 months	To evaluate the change of quantity of circulating tumor DNA with digital PCR

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of