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Trial record 6 of 127 for:    exosomes

Combined Diagnosis of CT and Exosome in Early Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03542253
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
gongjianping, Second Affiliated Hospital of Soochow University

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

Condition or disease Intervention/treatment
Early Lung Cancer Procedure: Surgery

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Other
Official Title: Combined Diagnosis of CT and Exosome in Early Lung Cancer
Estimated Study Start Date : May 20, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Target Reconstruction
micorRNA-A Plasma exocrine
micorRNA-A Paracancerous tiusse
pathologic diagnosis Procedure: Surgery
After surgical treatment, pathological specimens were extracted to obtain pathological results

micorRNA-A in plasma
Sample quality control
micorRNA-R in plasma
micorRNA-R in Plasma exocrine

Primary Outcome Measures :
  1. exosome in cancer tissue and para cancerous tissue [ Time Frame: one year ]
    exosomal micor-A was highly expressed in early stage lung cancer tissues

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.


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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Responsible Party: gongjianping, Combined diagnosis of CT and exosome in early lung cancer, Second Affiliated Hospital of Soochow University Identifier: NCT03542253     History of Changes
Other Study ID Numbers: 123456
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by gongjianping, Second Affiliated Hospital of Soochow University:
Early lung cancer,ground-glass nodule,CT,exosome
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases