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Trial Title:
Analysis of Plasma Tumor DNA in Lung Cancer Patients
NCT ID:
NCT01930474
Condition:
Non Small Cell Lung Cancer Patients
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer, plasma DNA, free DNA, EGFR, ALK
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
The non-small cell lung cancer patients who will be or have been treated with
chemotherapy (including target agents)
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyun, Chang
Phone:
82-31-787-7039
Email:
mobitz@hanmail.net
Start date:
July 2013
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01930474
