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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xuan Wang
• Email: dst.ding@gmail.com
• Phone: +8613524594847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.