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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07399210

Acronym

SHC2408

Enrollment

240

Registered

2026-02-10

Start date

2024-08-21

Completion date

2026-08-21

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragmentomics, Lung Cancer (Diagnosis)

Keywords

Fragmentomics, Lung Cancer(Diagnosis), cfDNA, Small Nodule, Non-invasive

Brief 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.

Interventions

OTHERThis study did not include intervention between two cohorts

This study did not include intervention between two cohorts

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules.	1 year

Countries

China

Contacts

CONTACTXuan Wang

dst.ding@gmail.com+8613524594847

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026