An observational study in Non Small Cell Lung Cancer Patients, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2013-12-05.
Sponsored by Seoul National University Hospital · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 200 is close to the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)
Exclusion Criteria:
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
Time frame: 60 months
Quantifying circulating tumor DNA in serially collected plasma specimens
To evaluate the change of quantity of circulating tumor DNA with digital PCR
Time frame: 60 months
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.
Time frame: 24 months
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital