Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics

ConditionsLung Cancer (Diagnosis)Fragmentomics

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBaohui Han

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

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;

Disqualifiers

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);

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Training Cohort1 intervention

Group B: Validation Cohort1 intervention

Trial outcomes

Primary outcomes

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

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baohui Han

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Source ClinicalTrials.gov

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