Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary… (NCT04182893) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules
China400 participantsStarted 2019-10-08
Plain-language summary
This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age ≥18 years old; The diameter of pulmonary lesions is 0.5-3cm in chest CT within 3 months; Healthy patients in normal control group had a smoking index ≥400; Patients who are eligible and intend to bronchoscopy.
Exclusion Criteria:
The patient received blood transfusion within 1 month； Patients suffer from autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, etc； Patients with cardiopulmonary dysfunction or other taboos, not suitable for bronchoscopy; Patients refused to participate in this clinical trial; The investigator considerates that the patient has other conditions that is unsuitable for this clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic efficiency of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules.