Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-01-31

Brief Summary

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

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Detailed Description

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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

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Lung Cancer Diagnoses Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung cancer

Circulating Tumor DNA Methylation Sequencing

Intervention Type DIAGNOSTIC_TEST

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

Benign pulmonary disease

Circulating Tumor DNA Methylation Sequencing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Circulating Tumor DNA Methylation Sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No