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Liquid Biopsy Using Methylation Sequencing for Lung Cancer

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ClinicalTrials.gov Identifier: NCT04253509
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
EDGC Inc.
Information provided by (Responsible Party):
Sang-Won Um, Samsung Medical Center

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

Condition or disease Intervention/treatment
Lung Cancer Diagnoses Disease Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

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.

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lung cancer Diagnostic Test: Circulating Tumor DNA Methylation Sequencing
Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Benign pulmonary disease Diagnostic Test: Circulating Tumor DNA Methylation Sequencing
Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Diagnostic accuracy of ctDNA methylation sequencing [ Time Frame: 2 year ]
    Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers.

  2. Positive predictive value of ctDNA methylation sequencing [ Time Frame: 2 year ]
    Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of ctDNA methylation will be compared with that of tumor markers.

  3. Negative predictive value of ctDNA methylation sequencing [ Time Frame: 2 year ]
    Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of ctDNA methylation will be compared with that of tumor markers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253509


Contacts
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Contact: Sang-Won Um, MD, PhD +82-2-3410-1645 sangwonum@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sang-Won Um Um, M.D.    82-2-3410-1645    sangwonum@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
EDGC Inc.
Investigators
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Principal Investigator: Sang-Won Um, MD, PhD Samsung Medical Center
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Responsible Party: Sang-Won Um, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04253509    
Other Study ID Numbers: 2019-11-080
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sang-Won Um, Samsung Medical Center:
Lung Cancer
Methylation Sequencing
Liquid Biopsy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases