Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics

NCT07399210 | Recruiting

• 1 other identifier: ShanghaiChest2408
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis); Fragmentomics

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1 year

Study Arms (2)

Training Cohort

A group of 160 adults with imaging-detected lung nodules who will each provide a blood sample for cfDNA fragmentomics analysis. Data from this cohort will be used to train the diagnostic algorithm, teaching it to recognize the cfDNA patterns that distinguish benign from malignant nodules.

Other: This study did not include intervention between two cohorts

Validation Cohort

An independent set of 80 adults with similar imaging-detected lung nodules. These participants will undergo the same blood sampling and cfDNA analysis, and their confirmed diagnoses (benign or malignant) will be used to evaluate the algorithm's performance-measuring sensitivity, specificity, accuracy, and area under the ROC curve.

Other: This study did not include intervention between two cohorts

Interventions

This study did not include intervention between two cohorts OTHER

This study did not include intervention between two cohorts

Training Cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adults (≥18 years old) with CT-detected pulmonary nodules of specified types and sizes, who are willing to undergo diagnostic confirmation and provide a peripheral blood sample prior to treatment. Participants must not have received cancer therapy within the last 3 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baohui Han: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuan Wang

CONTACT

+8613524594847; dst.ding@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: February 10, 2026
• Study Start: August 21, 2024
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CN (1)