Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

NCT03989219 | Completed DMC

• 1 other identifier: SHCHE201802
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.

Conditions

Pulmonary Nodule, Solitary

Keywords

cfDNA methylation; CT follow-up; plasma; pulmonary nodule

Outcome Measures

Primary Outcomes (1)

• The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules

  The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .

  12 months

Study Arms (1)

lung nodules were found by CT scanning

Plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.

Procedure: plasma cfDNA methylation

Interventions

plasma cfDNA methylation PROCEDURE

plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.

lung nodules were found by CT scanning

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of this study are those who meet the inclusion and exclusion criteria.

You may qualify if:

• Aged 40-80;
• Lung nodules were detected by CT (≥5mm，≤3cm);
• Patients fully understand the informed consent and can sign the informed consent in person.

You may not qualify if:

• Patients diagnosed with malignant tumors in the past;
• This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
• Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
• Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
• The researchers concluded that there were other conditions that made it inappropriate to participate in this study

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Li Y, Xie F, Zheng Q, Zhang Y, Li W, Xu M, He Q, Li Y, Sun J. Non-invasive diagnosis of pulmonary nodules by circulating tumor DNA methylation: A prospective multicenter study. Lung Cancer. 2024 Sep;195:107930. doi: 10.1016/j.lungcan.2024.107930. Epub 2024 Aug 11.

  PMID: 39146624 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Total cfDNA was extracted from 10ml plasma.

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 18, 2019
• Study Start: August 15, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)