Recruiting
Observational
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
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
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)
- Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules. — 1 year
Trial sites (1)
| Facility | City | Region | Status |
| Shanghai Chest Hospital |
Shanghai |
Shanghai Municipality |
Recruiting |
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