RecruitingNCT07399210

Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics

A Prospective Clinical Study Evaluating the Noninvasive Use of Circulating Cell-Free DNA Fragmentomics to Differentiate Benign and Malignant Lung Nodules, With Emphasis on Small Nodules.

Sponsor

Baohui Han

Enrollment

240 participants

Start Date

Aug 21, 2024

Study Type

OBSERVATIONAL

Conditions

Lung Cancer (Diagnosis)Fragmentomics

Summary

The goal of this observational study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether analyzing patterns in cell-free DNA (tiny fragments of DNA that tumors release into the bloodstream) can accurately detect whether small lung nodules found on CT scans are cancerous or benign — potentially sparing patients from unnecessary invasive procedures. **You may be eligible if...** - You are 18 or older - You had a low-dose CT scan showing a lung nodule between 5–20 mm (solid or part-solid) or 8–30 mm (pure ground-glass opacity) - Your nodule has been confirmed as benign or malignant by biopsy, surgery, or at least 2 years of imaging follow-up **You may NOT be eligible if...** - Your nodule is outside the size range specified - You have other active cancers that could complicate the DNA analysis - You are unable to provide a blood sample for the cfDNA test Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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