Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: This study did not include intervention between two cohorts.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Diagnosis), Fragmentomics. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
- Other This study did not include intervention between two cohorts
This study did not include intervention between two cohorts
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07399210 · ShanghaiChest2408