Lung CancerNCT04253509
Liquid Biopsy Using Methylation Sequencing for Lung Cancer
An observational study of Lung Cancer and Diagnoses Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Lung Cancer, Diagnoses Disease
- What is being tested?
- Circulating Tumor DNA Methylation Sequencing
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2020to 31 Jan 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Lung cancer 1. Pathologically proven lung cancer 2. Clinically suspected lung cancer on chest CT scan 1. nodule, mass, pulmonary infiltrate, or consolidation 2. size : diameter at least 1 cm 3. CT attenuation of solid or part-solid 4. planned to follow-up, biopsy, or surgical resection * Benign pulmonary disease 1. COPD : post bronchodilator FEV1/FVC < 0.7 and FEV1 pred < 80% 2. ILD : either histologic or clinical diagnosis 3. Pneumonia : community or hospital acquired 4. Bronchiectasis : chest CT diagnosis 5. NTM : at least 2 isolation of pathogen from sputum 6. Pulmonary vascular disease : embolism, pulmonary hypertension, arteriovenous malformation
Who may be able to join
- Lung cancer group
- Pathologically proven lung cancer
- Clinically suspected lung cancer on chest CT scan
- Benign pulmonary disease group
- Chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease
Who cannot join
- Patients with previous history of lung cancer
- Patients who have been diagnosed with other malignancy within 5 years
- Unstable vital status
- Active pulmonary tuberculosis
- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
Read the detailed description
Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.
- Conditions
- Lung Cancer, Diagnoses Disease
- Being tested
- Circulating Tumor DNA Methylation Sequencing
- Keywords
- Lung Cancer, Methylation Sequencing, Liquid Biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor DNA Methylation SequencingDiagnostic test
Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Not described Receives: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing | |
| Benign pulmonary disease | Not described Receives: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of ctDNA methylation sequencing
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.
Measured: 2 year
Diagnostic specificity of ctDNA methylation sequencing
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.
Measured: 2 year
Secondary outcomes (3)
Diagnostic accuracy of ctDNA methylation sequencing
Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers.
Measured: 2 year
Positive predictive value of ctDNA methylation sequencing
Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of ctDNA methylation will be compared with that of tumor markers.
Measured: 2 year
Negative predictive value of ctDNA methylation sequencing
Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of ctDNA methylation will be compared with that of tumor markers.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Feb 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- EDGC Inc.
- Responsible party
- Principal investigator, Sang-Won Um, Samsung Medical Center
- Investigators
- Sang-Won Um, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253509
- Sponsor's protocol ID
- 2019-11-080
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwon HJ, Shin SH, Kim HH, Min NY, Lim Y, Joo TW, Lee KJ, Jeong MS, Kim H, Yun SY, Kim Y, Park D, Joo J, Bae JS, Lee S, Jeong BH, Lee K, Lee H, Kim HK, Kim K, Um SW, An C, Lee MS. Advances in methylation analysis of liquid biopsy in early cancer detection of colorectal and lung cancer. Sci Rep. 2023 Aug 19;13(1):13502. doi: 10.1038/s41598-023-40611-w.
PubMed 37598236
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT04253509
- Acronym / sponsor ID
- 2019-11-080
- Conditions
- Lung Cancer, Diagnoses Disease
- Keywords
- Lung Cancer, Methylation Sequencing, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- EDGC Inc.
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Feb 2020 (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 investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
Detailed description
Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing |
| Benign pulmonary disease | – | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Lung cancer 1. Pathologically proven lung cancer 2. Clinically suspected lung cancer on chest CT scan 1. nodule, mass, pulmonary infiltrate, or consolidation 2. size : diameter at least 1 cm 3. CT attenuation of solid or part-solid 4. planned to follow-up, biopsy, or surgical resection * Benign pulmonary disease 1. COPD : post bronchodilator FEV1/FVC < 0.7 and FEV1 pred < 80% 2. ILD : either histologic or clinical diagnosis 3. Pneumonia : community or hospital acquired 4. Bronchiectasis : chest CT diagnosis 5. NTM : at least 2 isolation of pathogen from sputum 6. Pulmonary vascular disease : embolism, pulmonary hypertension, arteriovenous malformation
Key inclusion criteria (5 listed)
- Lung cancer group
- Benign pulmonary disease group
Key exclusion criteria (5 listed)
- Patients with previous history of lung cancer
- Patients who have been diagnosed with other malignancy within 5 years
- Unstable vital status
- Active pulmonary tuberculosis
- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Circulating Tumor DNA Methylation SequencingWhole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing. | Diagnostic test | Benign pulmonary disease, Lung cancer |
Primary outcome
Diagnostic sensitivity of ctDNA methylation sequencing
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.
Diagnostic specificity of ctDNA methylation sequencing
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.
3 secondary outcomes
Diagnostic accuracy of ctDNA methylation sequencing
Time frame: 2 year
Positive predictive value of ctDNA methylation sequencing
Time frame: 2 year
Negative predictive value of ctDNA methylation sequencing
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 37598236Kwon HJ, Shin SH, Kim HH, Min NY, Lim Y, Joo TW, Lee KJ, Jeong MS, Kim H, Yun SY, Kim Y, Park D, Joo J, Bae JS, Lee S, Jeong BH, Lee K, Lee H, Kim HK, Kim K, Um SW, An C, Lee MS. Advances in methylation analysis of liquid biopsy in early cancer detection of colorectal and lung cancer. Sci Rep. 2023 Aug 19;13(1):13502. doi: 10.1038/s41598-023-40611-w.
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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.
Sang-Won Um, MD, PhD principal investigator
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 Lung Cancer and Diagnoses Disease, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic sensitivity of ctDNA methylation sequencing (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253509, which also lists 1 linked publication.
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 8 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.