Clinical trial NCT03542253: Combined Diagnosis of CT and Exosome in Early Lung Cancer
Official title: Combined Diagnosis of CT and Exosome in Early Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Lung Cancer
Keywords: Early lung cancer,ground-glass nodule,CT,exosome
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From November 2017 to June 2019, there were nodules on the lungs, both men and women, and patients of the same age who had CT target reconstruction and miRNA and ctDNA detection at the same time had complete follow-up data.

Brief summary: This experiment has now collected 50 cases, all through CT chest scans and blood exosome detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was highly expressed in early stage lung cancer tissues and was significantly higher than paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that in peripheral blood exosomes


Eligibility criteria: Inclusion Criteria:1. At least 18 years of age, male or female; 2. No patients with acute disease; 3. Chest or LDCT examination for the first time found 5-30mm pulmonary nodule patients, and ruled out disseminated tuberculosis; 4. Past pulmonary nodes Festival failed to diagnose. 5. Have not received a history of surgical treatment of the lungs; 6. Patients who have not received targeted drugs, biological treatments, immunosuppressive agents, and modulators; 7. No organ transplants; 8. Signed informed consent before undergoing clinical studies Consent and adherence to the research protocol.

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Exclusion Criteria:1. Pulmonary nodules have been treated surgically (considering that surgery has been performed to interfere with the study); 2. History of organ transplants such as lung transplantation (consider the use of allogeneic genes and immunosuppressive agents); 3. Pregnancy or lactation (consider Failure to perform regular CT follow-up and fetal component effects. 4. Known HIV-positive or only AIDS-related diseases (taking into account interference with the use of immune drugs); 5. Being targeted drugs, immunosuppressive agents, immunomodulators, biotherapies Patients; 6. Active pulmonary tuberculosis (consider infectious and referral missing factors); 7. RNA-like viral infections: such as SARS, HIV, hepatitis virus (except for hepatitis B, the other four are all RNA viruses), influenza virus, Bird flu virus, H5N1, Ebola, measles, etc. 8. Various blood system diseases such as leukemia, lymphoma, aplastic anemia, myelodysplastic syndrome, anemia, hemolysis, hemophilia, DIC, etc. 9. Recent history of blood transfusion (within 3\~6 years) and potential for blood transfusion; 10. Patients with neurological disorders and mental disorders unable to cooperate; 11. Emergency treatment for acute and severe diseases; 12. No Willing to sign a written informed consent and follow the study protocol before they are willing to conduct clinical research; 13. The presence of the patient may interfere with any psychological, family, social or geography conditions that obey the requirements of the research protocol or the follow-up procedure. Discuss these conditions with the patient before entering the study.

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Primary outcomes:
measure: exosome in cancer tissue and para cancerous tissue
timeFrame: one year
Secondary outcomes:
Other outcomes:
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