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Completed

NCT Number: NCT03989219

Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

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.

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Key information

Conditions

Pulmonary Nodule, Solitary Lung Diseases Respiratory Tract Diseases Solitary Pulmonary Nodule

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Inclusion criteria:
  • 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.

Exclusion criteria

  • 2. Exclusion criteria:
  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

    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 .

Sponsors and collaborators

Lead sponsor

Jiayuan Sun

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2019
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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