Pulmonary Nodules, Multiple Clinical Trial
Official title:
Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | February 29, 2024 |
| Est. primary completion date | February 29, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | China-Japan Friendship Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| China-Japan Friendship Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | sensitivity | the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy | until the samples are collected and tested as planned, up to 72 months | |
| Primary | specificity | the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease | until the samples are collected and tested as planned, up to 72 months |