Clinical trial · Observational
The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection
The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Methylation | — | UNRESOLVED | — |
| Red Blood Cells | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylation tests of nucleic acids extracted from mature red blood cells (RBCs) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with pulmonary nodules (diameter ≤3cm) plan to diagnosis benign and malignant
- description
- Patients with pulmonary nodules (diameter ≤3cm) plan to use biopsy or surgery or treatment to diagnosis benign and malignant.
- interventionNames
- Diagnostic Test: Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)
Primary outcomes (4)
- measure
- Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
- timeFrame
- 3 years
- measure
- Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
- timeFrame
- 3 years
- measure
- Positive predictive value (PPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pulmonary nodule is ≤3cm; 2. Subjects suspected of lung cancer; 3. Diagnosis or treatment by biopsy or surgery within 60 days; 4. Signed informed consent. Exclusion Criteria: 1. History of malignant tumors; 2. Received anti-tumor therapy; 3. Can't collect the histopathological results or the pathological results are metastatic cancer; 4. Can't obtain detection information of red blood cells; 5. Pregnancy or lactating female； 6. Other situations not suitable for the study.
References
Publications (0)
Data not yet available