NCT04253509

Brief Summary

This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 31, 2020

Last Update Submit

February 5, 2022

Conditions

Lung CancerDiagnoses Disease

Keywords

Lung CancerMethylation SequencingLiquid Biopsy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 year

Secondary Outcomes (3)

  • Diagnostic accuracy of ctDNA methylation sequencing

    2 year

  • Positive predictive value of ctDNA methylation sequencing

    2 year

  • Negative predictive value of ctDNA methylation sequencing

    2 year

Study Arms (2)

Lung cancer

Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

Benign pulmonary disease

Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

Interventions

Circulating Tumor DNA Methylation SequencingDIAGNOSTIC_TEST

Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Benign pulmonary diseaseLung cancer

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37598236DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sang-Won Um, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 3, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

KR(1)