Actively Recruiting
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
Led by Baohui Han · Updated on 2026-02-10
240
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Lung nodules detected on low-dose spiral CT with one of the following: solid or part-solid nodules between 5 mm and 20 mm, or pure ground-glass nodules between 8 mm and 30 mm
- If multiple nodules are present, the largest nodule must meet size criteria
- Lung nodule status (benign or malignant) can be clinically confirmed
- No cancer-directed therapy (chemotherapy, radiotherapy, immunotherapy, cell therapy) in the past 3 months
- Able to provide a 5 mL peripheral blood sample before any treatment
- Voluntarily signed informed consent after full explanation of the study
You will not qualify if you...
- Pregnant or breastfeeding
- Current or past diagnosis of malignant tumors within the past 5 years, except early-stage lung cancer patients who had surgery but still have multiple evaluable nodules
- Severe heart disease, serious liver or kidney disorders, or significant bone marrow hematopoietic dysfunction
- History of organ transplantation or blood transfusion within the past 3 months
- History of seropositivity for HIV
- Any other condition deemed inappropriate for study participation by the investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xuan Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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