Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
Recruiting now
Conditions studied: Lung Cancer (Diagnosis), Fragmentomics
In brief
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.
Key facts
- Study ID
- NCT07399210
- Run by
- Baohui Han
- People needed
- 240
- Starts
- 2024-08-21
- Expected to finish
- 2026-08-21
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years;
- Positive for lung nodules on low-dose spiral CT (LDCT) meeting one of the following criteria:
- Solid or part-solid nodules ≥ 5 mm and ≤ 20 mm; Pure ground-glass nodules ≥ 8 mm and ≤ 30 mm; In cases of multiple nodules, the largest nodule (by maximum diameter) must meet these criteria;
- Participants whose lung nodule status (benign or malignant) can be clinically confirmed;
- No cancer-directed therapy (e.g., chemotherapy, radiotherapy, immunotherapy, cell therapy) within the past 3 months;
- Able to provide a 5 mL peripheral blood sample prior to any treatment;
- Voluntary signing of informed consent after full explanation of the study.
You may not qualify if…
- Pregnant or breastfeeding;
- Current or past diagnosis (within the past 5 years) of malignant tumors (excluding patients with early-stage lung cancer who have undergone surgery but still have multiple evaluable nodules), or with 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 human immunodeficiency virus (HIV);
- Any other condition deemed inappropriate for study participation by the investigators.
Where it is running
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.