CClinicalTrials.gg
Status unknownNCT03542253Updated May 31, 2018

Combined Diagnosis of CT and Exosome in Early Lung Cancer

An observational study in Early Lung Cancer, sponsored by Second Affiliated Hospital of Soochow University. Status unknown. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Second Affiliated Hospital of Soochow University · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
80
Sex
All
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Study 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

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Conditions studied

  • Early Lung Cancer

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Keywords

  • Early lung cancer,ground-glass nodule,CT,exosome
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 80 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

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Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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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Study design

Observational model
Other
Time perspective
Other
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Age
  • Sex
  • triglyceride
  • Lipoprotein
  • CT

    Target Reconstruction

  • micorRNA-A Plasma exocrine
  • micorRNA-A Paracancerous tiusse
  • pathologic diagnosis

    Procedure: Surgery

  • hemolysis
  • ct-DNA
  • micorRNA-A in plasma
  • Sample quality control
  • positive
  • negative
  • micorRNA-R in plasma
  • micorRNA-R in Plasma exocrine
  • Surgery

Interventions

  • ProcedureSurgery

    After surgical treatment, pathological specimens were extracted to obtain pathological results

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What researchers measure

Primary outcomes

  1. exosome in cancer tissue and para cancerous tissue

    exosomal micor-A was highly expressed in early stage lung cancer tissues

    Time frame: one year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03542253
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
gongjianping (Combined diagnosis of CT and exosome in early lung cancer, Second Affiliated Hospital of Soochow University) — Principal investigator
First posted
May 31, 2018
Start date
May 20, 2018 (estimated)
Primary completion
May 30, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
May 31, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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