Early Lung CancerNCT03542253
Combined Diagnosis of CT and Exosome in Early Lung Cancer
An observational study of Early Lung Cancer, run by Second Affiliated Hospital of Soochow University.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Lung Cancer
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
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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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About this study
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
- Conditions
- Early Lung Cancer
- Being tested
- Surgery
- Keywords
- Early lung cancer,ground-glass nodule,CT,exosome
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
After surgical treatment, pathological specimens were extracted to obtain pathological results
| Study group | Role | What they receive |
|---|---|---|
| Age | Not described | |
| Sex | Not described | |
| triglyceride | Not described | |
| Lipoprotein | Not described | |
| CT | Target Reconstruction | |
| micorRNA-A Plasma exocrine | Not described | |
| micorRNA-A Paracancerous tiusse | Not described | |
| pathologic diagnosis | Not described Receives: Procedure: Surgery | |
| hemolysis | Not described | |
| ct-DNA | Not described | |
| micorRNA-A in plasma | Not described | |
| Sample quality control | Not described | |
| positive | Not described | |
| negative | Not described | |
| micorRNA-R in plasma | Not described | |
| micorRNA-R in Plasma exocrine | Not described | |
| Surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
exosome in cancer tissue and para cancerous tissue
exosomal micor-A was highly expressed in early stage lung cancer tissues
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 May 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gongjianping, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542253
- Sponsor's protocol ID
- 123456
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 31 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Diagnosis of CT and Exosome in Early Lung Cancer
- ClinicalTrials.gov ID
- NCT03542253
- Acronym / sponsor ID
- 123456
- Conditions
- Early Lung Cancer
- Keywords
- Early lung cancer,ground-glass nodule,CT,exosome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 20 May 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAfter surgical treatment, pathological specimens were extracted to obtain pathological results | Procedure or surgery | pathologic diagnosis |
Primary outcome
exosome in cancer tissue and para cancerous tissue
Time frame: one year
exosomal micor-A was highly expressed in early stage lung cancer tissues
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Lung Cancer, run by Second Affiliated Hospital of Soochow University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exosome in cancer tissue and para cancerous tissue (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.