Status:
COMPLETED
Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Pulmonary Nodules, Solitary
Pulmonary Nodules, Multiple
Eligibility:
All Genders
18+ years
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...
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 n...
Eligibility Criteria
Inclusion
- 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:
- 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;
- Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- Serum creatinine ≤1.5 times the upper limit of normal value.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT06187935
Start Date
January 1 2019
End Date
March 31 2024
Last Update
February 27 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029