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An Observational Study Exploring Invasive Markers of Pulmonary Nodules Based on Peripheral Blood DNA Methylation Detection Technology

Peripheral Blood DNA methylation-based diagnostic models for benign–malignant classification and invasiveness assessment of pulmonary nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119035
Enrollment
Unknown
Registered
2026-02-14
Start date
2026-02-23
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary nodules (diameter < 30 mm)

Interventions

Gold Standard:Histopathological diagnosis is used as the primary gold standard. Malignant pulmonary nodules must be confirmed by pathology, and classified as adenocarcinoma in situ/minimally invasive
Index test:The index test is a diagnostic assay based on peripheral blood DNA methylation analysis. Preoperative peripheral blood samples are collected for peripheral blood DNA methylation library con

Sponsors

Peking University Cancer Hospital & Institute, Beijing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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; 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

MeasureTime 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

shenluyan@bjmu.edu.cn+86 158 1140 8473

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026