NSCLC Stage IVNCT04932343
Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor
An observational study of NSCLC Stage IV and NSCLC Stage IIIB, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC Stage IV, NSCLC Stage IIIB
- What is being tested?
- cohort study
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 1 Dec 2022
- 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: Treatment naïve stage III-IV non-small cell lung cancer who undergoing surgery for any intent
Who may be able to join
- All subjects need to sign the informed consent form
- All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively
- Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)
- Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing
Who cannot join
- Patients with previous history of lung cancer
- Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
- Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC
This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Being tested
- cohort study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohort studyDiagnostic test
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The gene expression and the cell population
Methods for the single cell RNA sequencing and whole exome sequencing of the tumor cells With the tissue biopsied specimens, scRNAseq (by 10X Genomics platform) and whole exome seq will be carried out.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CytoGen, Inc., UNIST (Ulsan National Institute of Science and Technology)
- Responsible party
- Principal investigator, Jhingook Kim, MD, Samsung Medical Center
- Investigators
- Jhingook Kim, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932343
- Sponsor's protocol ID
- IRB 2019-07-101
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Jun 2021
- 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04932343
- Acronym / sponsor ID
- IRB 2019-07-101
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- CytoGen, Inc., UNIST (Ulsan National Institute of Science and Technology)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Jun 2021 (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.
This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Treatment naïve stage III-IV non-small cell lung cancer who undergoing surgery for any intent
Key inclusion criteria (4 listed)
- All subjects need to sign the informed consent form
- All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively
- Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)
- Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing
Key exclusion criteria (3 listed)
- Patients with previous history of lung cancer
- Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
- Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment
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 |
|---|---|---|
| cohort studyno intervention | Diagnostic test | – |
Primary outcome
The gene expression and the cell population
Time frame: 3 year
Methods for the single cell RNA sequencing and whole exome sequencing of the tumor cells With the tissue biopsied specimens, scRNAseq (by 10X Genomics platform) and whole exome seq will be carried out.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- 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.
Jhingook Kim, MD study chair
Samsung Medical Center
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 NSCLC Stage IV and NSCLC Stage IIIB, run by Samsung Medical Center 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 4 inclusion and 3 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 21 Jun 2021. 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?
The gene expression and the cell population (time frame: 3 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 21 Jun 2021.