Pulmonary nodules (diameter < 30 mm)
Conditions
Interventions
Index test:The index test is a diagnostic assay based on plasma cell-free DNA (cfDNA) methylation analysis. Preoperative peripheral blood samples are collected for cfDNA methylation library constructi
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or over 2. Individuals with pulmonary nodules smaller than 30mm detected by chest CT, confirmed through follow-up and pathological diagnosis. For malignant pulmonary nodules, a definitive pathological diagnosis is required; for benign pulmonary nodules, either a definitive pathological diagnosis or a diagnosis by two experienced clinicians is required.
Exclusion criteria
Exclusion criteria: 1.Having received anti-tumour treatment (such as surgery, radiotherapy, ablation, chemotherapy, or targeted therapy) before or at the time of blood sampling, except for antibiotic therapy; 2.Concurrent or previous history of other malignancies, including but not limited to adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer after radical therapy, and ductal carcinoma in situ after radical treatment; 3.Absence of pathological results of the pulmonary lesion, or pathology indicating a metastatic tumour derived from another organ or other special pathological types; 4.History of solid organ transplantation or allogeneic haematopoietic stem cell transplantation; 5.Haematological diseases, or receipt of blood products within 6 months prior to blood sampling; 6.Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Area under the ROC curve (AUC) and its 95% confidence interval.; | — |
Countries
China
Contacts
Public ContactShen Luyan
Peking University Cancer Hospital & Institute, Beijing
Outcome results
None listed