Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989219
• Other study ID #: SHCHE201802
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Inclusion criteria:

1. Aged 40-80;

2. Lung nodules were detected by CT (=5mm,=3cm);

3. Patients fully understand the informed consent and can sign the informed consent in person.

Exclusion Criteria:

• 2. Exclusion criteria:

1. Patients diagnosed with malignant tumors in the past;

2. This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement;

3. Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies;

4. Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.

5. The researchers concluded that there were other conditions that made it inappropriate to participate in this study

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Procedure:
• plasma cfDNA methylation
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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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