Clinical trial NCT04253509: Liquid Biopsy Using Methylation Sequencing for Lung Cancer
Official title: Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Diagnoses Disease
Keywords: Lung Cancer
Methylation Sequencing
Liquid Biopsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: EDGC Inc.
First posted: 2020-02-05
Enrollment: 280
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Lung cancer group

  1. Pathologically proven lung cancer
  2. 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Diagnostic sensitivity of ctDNA methylation sequencing
timeFrame: 2 year
measure: Diagnostic specificity of ctDNA methylation sequencing
timeFrame: 2 year
Secondary outcomes:
measure: Diagnostic accuracy of ctDNA methylation sequencing
timeFrame: 2 year
measure: Positive predictive value of ctDNA methylation sequencing
timeFrame: 2 year
measure: Negative predictive value of ctDNA methylation sequencing
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sang-Won Um, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: