Analysis of Plasma Tumor DNA in Lung Cancer Patients

Non Small Cell Lung Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930474
• Other study ID #: 02-2013-105
• Secondary ID: B-1307/210-005
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2013
• Last updated: December 3, 2013
• Start date: July 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: Hyun Chang, Dr.
• Phone: 82-31-787-7039
• Email: Hchang[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Patients

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Quantifying circulating tumor DNA in serially collected plasma specimens	To evaluate the change of quantity of circulating tumor DNA with digital PCR	60 months	No