Non Small Cell Lung Cancer PatientsNCT01930474
Analysis of Plasma Tumor DNA in Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer Patients, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer Patients
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)
Who may be able to join
- 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
Who cannot join
- Patients who refuse the blood samplings
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyun, Chang, 82-31-787-7039, mobitz@hanmail.net
About this study
Official title: Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA
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.
- Conditions
- Non Small Cell Lung Cancer Patients
- Keywords
- lung cancer, plasma DNA, free DNA, EGFR, ALK
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 months
Secondary outcomes (1)
Quantifying circulating tumor DNA in serially collected plasma specimens
To evaluate the change of quantity of circulating tumor DNA with digital PCR
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Chang, Seoul National University Hospital
- Investigators
- Hyun Chang, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930474
- Sponsor's protocol ID
- 02-2013-105
- Other IDs
- B-1307/210-005
- Status last verified
- Dec 2013
- First submitted
- 21 Aug 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA
- ClinicalTrials.gov ID
- NCT01930474
- Acronym / sponsor ID
- 02-2013-105
- Conditions
- Non Small Cell Lung Cancer Patients
- Keywords
- lung cancer, plasma DNA, free DNA, EGFR, ALK
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2018 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refuse the blood samplings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of genetic alterations (including EGFR and ALK) in plasma samples
Time frame: 60 months
To evaluate the sensitivity of digital PCR to detect the genetic alterations in plasma tumor DNA
1 secondary outcome
Quantifying circulating tumor DNA in serially collected plasma specimens
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Chang principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer Patients, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Chang, Dr. (82-31-787-7039, Hchang@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of genetic alterations (including EGFR and ALK) in plasma samples (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.