NCT06056999 New Method to Differentiate Benign and Malignant Pulmonary Nodules.
| NCT ID | NCT06056999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Pulmonary Nodules |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-09-29 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years; * CT imaging shows the presence of pulmonary nodule \<3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed; * Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2; * Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine \<178μmol/L; * Subjects must have the ability to understand and sign the informed consent in writing voluntarily. Exclusion Criteria: * Imaging examination have suggested the possibility of metastasis at other sites; * ≥2 target lesions with different type categorized by density; * History of malignant disease; * Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled; * The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.; * History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent; * Pregnant or breastfeeding women; * Other conditions deemed by the investigator to be unsuitable for enrollment.
Contact & Investigator
Guangying Zhu
PRINCIPAL INVESTIGATOR
China-Japan Friendship Hospital
Frequently Asked Questions
Who can join the NCT06056999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Nodules. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06056999 currently recruiting?
Yes, NCT06056999 is actively recruiting participants. Contact the research team at zryyfa@163.com for enrollment information.
Where is the NCT06056999 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06056999 clinical trial?
NCT06056999 is sponsored by China-Japan Friendship Hospital. The principal investigator is Guangying Zhu at China-Japan Friendship Hospital. The trial plans to enroll 150 participants.