NCT03181490

Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules

Completed Last updated 2 April 2020

What this trial tests

trial testing Circulating Tumor DNA Methylation Test in Pulmonary Nodule, Solitary in 1,490 participants. Completed in 31 May 2019.

Timeline

8 June 2017

Primary endpoint
28 February 2019

31 May 2019

Quick facts

Lead sponsor	The First Affiliated Hospital of Guangzhou Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,490
Start date	8 June 2017
Primary completion	28 February 2019
Estimated completion	31 May 2019
Sites	14 locations across China

Drugs / interventions tested

• Circulating Tumor DNA Methylation Test

Conditions studied

• Pulmonary Nodule, Solitary — all drugs for Pulmonary Nodule, Solitary →

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Who can join

18 and older, any sex, with Pulmonary Nodule, Solitary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples.

In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-invasive diagnosis of early-stage lung cancer using high-throughput targeted DNA methylation sequencing of circulating tumor DNA (ctDNA).
   Liang W, Zhao Y, Huang W, Gao Y, et al · · 2019 · cited 189× · PMID 31037156 · DOI 10.7150/thno.28119
2. Advances in lung cancer screening and early detection.
   Li C, Wang H, Jiang Y, Fu W, et al · · 2022 · cited 61× · PMID 35535966 · DOI 10.20892/j.issn.2095-3941.2021.0690
3. Accurate classification of pulmonary nodules by a combined model of clinical, imaging, and cell-free DNA methylation biomarkers: a model development and external validation study.
   He J, Wang B, Tao J, Liu Q, et al · · 2023 · cited 53× · PMID 37567793 · DOI 10.1016/s2589-7500(23)00125-5
4. Circulating tumor DNA methylation detection as biomarker and its application in tumor liquid biopsy: advances and challenges.
   Li L, Sun Y. · · 2024 · cited 52× · PMID 39525954 · DOI 10.1002/mco2.766
5. An annual review of the remarkable advances in lung cancer clinical research in 2019.
   Cheng B, Xiong S, Li C, Liang H, et al · · 2020 · cited 21× · PMID 32274174 · DOI 10.21037/jtd.2020.03.11
6. DNA methylation in human diseases.
   Younesian S, Mohammadi MH, Younesian O, Momeny M, et al · · 2024 · cited 16× · PMID 38933971 · DOI 10.1016/j.heliyon.2024.e32366
7. A clinically effective model based on cell-free DNA methylation and low-dose CT for risk stratification of pulmonary nodules.
   Liang W, Tao J, Cheng C, Sun H, et al · · 2024 · cited 11× · PMID 39341207 · DOI 10.1016/j.xcrm.2024.101750
8. Exploring the Potential of Non-Coding RNAs as Liquid Biopsy Biomarkers for Lung Cancer Screening: A Literature Review.
   Garbo E, Del Rio B, Ferrari G, Cani M, et al · · 2023 · cited 11× · PMID 37835468 · DOI 10.3390/cancers15194774