Clinical trial · Observational
Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.
Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.
- 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)
The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). Participants will be asked provide 4mL of peripheral blood for the test.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Nodules, Multiple | — | UNRESOLVED | — |
| Pulmonary Nodules, Solitary | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- pulmonary nodule group
- description
- Patients with pulmonary nodules no more than 3cm on CT imaging.
Primary outcomes (2)
- measure
- sensitivity
- timeFrame
- until the samples are collected and tested as planned, up to 72 months
- description
- the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy
- measure
- specificity
- timeFrame
- until the samples are collected and tested as planned, up to 72 months
- description
- the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Patients with single or multiple pulmonary nodules on CT imaging; 2. Subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study; 3. Subjects are generally in good condition, with ECOG score 0-1 and life expectancy of no less than 2 months; 4. Organ function level requirements: 1. Peripheral blood: 1.5 x 10\^9/L≤ absolute neutrophil count (ANC) ≤15 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin ≥9.0 g/dL; Prothrombin time (PT) ≥11 seconds, International normalized ratio (INR) ≥0.8; 2. Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal; 3. Serum creatinine ≤1.5 times the upper limit of normal value. Exclusion Criteria: 1\. The subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to ICU, CCU or other intensive care units due to cardiovascular and cerebrovascular diseases, or EF≤50%); b. Severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (HIV, HBV, HCV, etc.) within 3 months; 3. Poor compliance, unable to cooperate with the research program; 4. Participants in any drug trial within three months prior to enrollment; 5. Pregnant or breastfeeding; 6. Puncture/Surgical contraindications.
References
Publications (0)
Data not yet available