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Clinical Trials in China / NCT07399210
Recruiting Observational

Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics

NCT07399210 · tracked via the Priya Life Science China tracker
Sponsor
Baohui Han
Phase
Observational
Started
2024-08-21
Last updated
2026-02-10

Condition(s) studied

Lung Cancer (Diagnosis)Fragmentomics

Investigational drug(s) / intervention(s)

This study did not include intervention between two cohorts

This study did not include intervention between two cohorts: This study did not include intervention between two cohorts

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07399210 on ClinicalTrials.gov ↗ ← All trials in China