Non Small Cell Lung Cancer MetastaticCAPABLENCT03235765
Cancer Panel From Blood of Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer Recurrent, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- What is being tested?
- MACROGEN Pan Cancer Panel (Tier 2)
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2017to 10 Mar 2020
- How long will I take part?
- 3 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inoperable non-small cell lung cancer with two cohorts as below: 1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy 2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.
Who may be able to join
- Provision of informed consent prior to any study specific procedures, sampling, and analyses
- Pathologically confirmed non-small cell lung cancer
- Male or female, aged at least 20 years
- Matches one of two criteria :
- Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy
- Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.
Who cannot join
- Any concurrent and/or other active malignancy that has required treatment within 3 years
- Patients with mixed small cell histology
- Life expectancy less than 3 months
- Insufficient tissue for NGS test
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).
Read the detailed description
This study is comprised of two cohorts as below:
Cohort A: inoperable, untreated, non-small cell lung cancer patients
Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors
- Being tested
- MACROGEN Pan Cancer Panel (Tier 2)
- Keywords
- NSCLC, Cancer panel, NGS, Actionable mutation, Immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACROGEN Pan Cancer Panel (Tier 2)Diagnostic test
This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy Receives: Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2) | |
| Cohort B | Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent. Receives: Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate
Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA
Measured: an average of one year
Secondary outcomes (3)
Overall survival
To evaluate prognostic role of ctDNA concentration in NSCLC
Measured: an average of one year
Frequency of actionable genomic change
To determine the frequency of actionable oncogenic genes in NSCLC
Measured: an average of one year
Overall survival by treatment
To evaluate the survival of patients treated with genotype-directed therapy in daily practice
Measured: an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start10 Mar 2017
- Primary completion10 Mar 2019 (estimated)
- Study completion10 Mar 2020 (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 MetastaticStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MACROGEN
- Responsible party
- Principal investigator, Jong-Seok Lee, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235765
- Sponsor's protocol ID
- SNUBH-17-01
- Acronym
- CAPABLE
- Status last verified
- Jan 2019
- First submitted
- 28 Jul 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT03235765
- Acronym / sponsor ID
- CAPABLE / SNUBH-17-01
- Keywords
- NSCLC, Cancer panel, NGS, Actionable mutation, Immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- MACROGEN
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 10 Mar 2019 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 1 Aug 2017 (actual)
- 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.
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).
Detailed description
This study is comprised of two cohorts as below:
Cohort A: inoperable, untreated, non-small cell lung cancer patients
Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy |
| Cohort B | – | Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inoperable non-small cell lung cancer with two cohorts as below: 1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy 2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.
Key inclusion criteria (6 listed)
- Provision of informed consent prior to any study specific procedures, sampling, and analyses
- Pathologically confirmed non-small cell lung cancer
- Male or female, aged at least 20 years
- Matches one of two criteria :
Key exclusion criteria (4 listed)
- Any concurrent and/or other active malignancy that has required treatment within 3 years
- Patients with mixed small cell histology
- Life expectancy less than 3 months
- Insufficient tissue for NGS test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACROGEN Pan Cancer Panel (Tier 2)This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes. | Diagnostic test | Cohort A, Cohort B |
Primary outcome
Concordance rate
Time frame: an average of one year
Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA
3 secondary outcomes
Overall survival
Time frame: an average of one year
Frequency of actionable genomic change
Time frame: an average of one year
Overall survival by treatment
Time frame: an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic and Non Small Cell Lung Cancer Recurrent, 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 6 inclusion and 4 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 22 Jan 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate (time frame: an average of one year). 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 22 Jan 2019.