Blood test using cfDNA fragment patterns to tell if a lung nodule is cancer

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.

This project will see if a blood test that analyzes cfDNA fragments can tell adults with CT-detected lung nodules whether the nodules are benign or malignant.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07399210 on ClinicalTrials.gov

What this trial studies

This observational study collects a 5 mL peripheral blood sample from adults with imaging-detected lung nodules and analyzes cell-free DNA fragmentomics to look for patterns that differ between benign and malignant nodules. Eligible nodules must meet specified size criteria and the nodule status must be clinically confirmed; participants should not have had cancer-directed therapy in the prior three months. No interventions are assigned; researchers will compare fragmentomic signatures between confirmed benign and malignant cases to determine diagnostic accuracy. All enrollment and sample collection are conducted at Shanghai Chest Hospital.

Who should consider this trial

Good fit: Adults (≥18 years) with CT-detected lung nodules that meet the study's size criteria, who can provide a 5 mL blood sample and have nodule status clinically confirmed without recent cancer-directed therapy, are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have had a recent (within 5 years) other malignancy, have severe comorbid organ disease, have nodules outside the specified size ranges, or cannot provide a pre-treatment blood sample are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the test could provide a noninvasive blood-based way to help decide which lung nodules need biopsy or surgery, potentially reducing unnecessary invasive procedures.

How similar studies have performed: Early research on cfDNA fragmentomics has shown promising results for detecting cancer-related signals in blood, but the approach remains experimental and is not yet standard clinical practice.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xuan Wang

Conditions Lung Cancer; Fragmentomics; cfDNA; Small Nodule; Non-invasive