Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary
Conditions
Brief summary
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.
Detailed description
The aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. Peripheral blood of participants will be collected before surgery or biopsy. Clinical and imaging data of enrolled patients will also be collected. Pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. The sensitivity and specificity of CTC detection for diagnosing malignant pulmonary nodules will be analyzed.
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity | until the samples are collected and tested as planned, up to 72 months | the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy |
| specificity | until the samples are collected and tested as planned, up to 72 months | the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease |
Countries
China
Outcome results
None listed