Noninvasive Detection of Lung Nodule Malignancy Using cfDNA 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
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 design
Treatments tested in this trial
- This study did not include intervention between two cohorts
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Baohui Han
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Source ClinicalTrials.gov