Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics (NCT07399210) | Clinical Trial Compass
RecruitingNot Applicable
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
China240 participantsStarted 2024-08-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules.