NCT07399210Recruiting
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.
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 10 Aug 2025
- Start date
- 21 Aug 2024
- Primary completion date
- 21 Aug 2026
- Lead sponsor
- Baohui Han
- Diseases
- Lung cancer
- NCT number
- NCT07399210
What you commit to
- Study type: Observational
- Planned participants: 240
- From 21 Aug 2024 to the primary completion date, 21 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant or breastfeeding;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.