Analysis of Plasma Tumor DNA in Lung Cancer Patients
Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA
2 other identifiers
observational
200
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 21, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedDecember 5, 2013
December 1, 2013
5.4 years
August 21, 2013
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quantifying circulating tumor DNA in serially collected plasma specimens
60 months
Other Outcomes (1)
Analysis of genetic alterations related with drug-resistance with next generation genome sequencing
24 months
Eligibility Criteria
The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)
You may qualify if:
- 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
You may not qualify if:
- Patients who refuse the blood samplings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Chang
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 21, 2013
First Posted
August 29, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2018
Last Updated
December 5, 2013
Record last verified: 2013-12