Analysis of Plasma Tumor DNA in Lung Cancer Patients

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01930474

Enrollment

200

Registered

2013-08-29

Start date

2013-07-31

Completion date

Unknown

Last updated

2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer Patients

Keywords

lung cancer, plasma DNA, free DNA, EGFR, ALK

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

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

Countries

South Korea

Contacts

Primary ContactHyun Chang, Dr.

Hchang@snubh.org82-31-787-7039

Outcome results