Analysis of Plasma Tumor DNA in Lung Cancer Patients

Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer Patients

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Hyun, Chang; Phone Number: 82-31-787-7039; Email: mobitz@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)

Description

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

Exclusion Criteria:

• Patients who refuse the blood samplings

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantifying circulating tumor DNA in serially collected plasma specimens	To evaluate the change of quantity of circulating tumor DNA with digital PCR	60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of genetic alterations related with drug-resistance with next generation genome sequencing	The tumor DNA will be sequenced and analyzed with NGS to detect the genetic alterations related with drug-resistance.	24 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hyun Chang, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: lung cancer, plasma DNA, free DNA, EGFR, ALK
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 02-2013-105; B-1307/210-005 (Other Identifier: SeoulNUH)