Lung Cancer (Diagnosis)NCT03830619
Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis
An observational study of Lung Cancer (Diagnosis), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- collect samples
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Jul 2021
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.
Who may be able to join
- Subjects are willing to sign the informed consent form;
- Normal subjects have no evidence of any disease;
- Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology
Who cannot join
- People are unwilling to sign the informed consent form;
- Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease;
- Pregnant or lactating women;
- Patients did not cooperate or participate in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer
Read the detailed description
Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC). The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study, exosomes from the plasma of five healthy individuals and 30 LC patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- collect samples
- Keywords
- exosomes；lncRNA； lung cancer；
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect samplesDiagnostic test
collect serum samples and clinical features
| Study group | Role | What they receive |
|---|---|---|
| lung cancer patients | Not described Receives: Diagnostic Test: collect samples | |
| normol volunteers | Not described Receives: Diagnostic Test: collect samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression levels of serum exosome long non-coding RNA
Measured: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1
Measured: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the CT scans of the lung for the patients
Measured: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830619
- Sponsor's protocol ID
- WuhanUH2018
- Status last verified
- Nov 2021
- First submitted
- 24 Jan 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD now
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT03830619
- Acronym / sponsor ID
- WuhanUH2018
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- exosomes；lncRNA； lung cancer；
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 5 Feb 2019 (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.
The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer
Detailed description
Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC). The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study, exosomes from the plasma of five healthy individuals and 30 LC patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung cancer patients | – | Diagnostic Test: collect samples |
| normol volunteers | – | Diagnostic Test: collect samples |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.
Key inclusion criteria (3 listed)
- Subjects are willing to sign the informed consent form;
- Normal subjects have no evidence of any disease;
- Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology
Key exclusion criteria (4 listed)
- People are unwilling to sign the informed consent form;
- Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease;
- Pregnant or lactating women;
- Patients did not cooperate or participate in other clinical trials
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 |
|---|---|---|
| collect samplescollect serum samples and clinical features | Diagnostic test | lung cancer patients, normol volunteers |
Primary outcome
The expression levels of serum exosome long non-coding RNA
Time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1
Time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the CT scans of the lung for the patients
Time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. no plan to share IPD now
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The expression levels of serum exosome long non-coding RNA (time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study). The study lists 3 primary outcomes in all. 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 22 Nov 2021.