the Relationship Between the Tumor Markers and Interstitial Lung Disease PatientsNCT04597814
The Relationship Between the Tumor Markers and Interstitial Lung Disease
An observational study of the Relationship Between the Tumor Markers and Interstitial Lung Disease Patients, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients. This study was undertaken to investigate the source of these serum tumor markers. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- the Relationship Between the Tumor Markers and Interstitial Lung Disease Patients
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 15 Oct 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung disease patients for lung transplantation
Who may be able to join
- 1.Interstitial lung disease patients for lung transplantation
- -
Who cannot join
- tumor
- Interstitial lung disease patients could not be performed by lung transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 520120
About this study
The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.
This study was undertaken to investigate the source of these serum tumor markers.
Read the detailed description
The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.
This study was undertaken to investigate the source of these serum tumor markers.We hypothesis that these tumor markers are released from the lung.
The broncholveolr lvge fluid levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 were measured in the interstitial lung disease patients before lung transplantation. The immunohistochemical test was performed in the specimen lung after lung transplantation.
- Being tested
- No Intervention
- Keywords
- carcinoembryonic antigen, carbohydrate antigen 19-9, carbohydrate antigen 125
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| interstitial lung disease patients | interstitial lung disease patients who need lung transplantation Receives: Other: No Intervention | |
| non- interstitial lung disease patients | non- interstitial lung disease patients who need thoracic surgery to remove pneumatocele Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of carcinoembryonic antigen (CEA)
serum levels of carcinoembryonic antigen (CEA)
Measured: 6months
serum levels of carbohydrate antigen 19-9 (CA19-9)
serum levels of carbohydrate antigen 19-9 (CA19-9)
Measured: 6months
serum levels of carbohydrate antigen 125(CA125)
serum levels of carbohydrate antigen 125(CA125)
Measured: 6months
The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)
The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)
Measured: 1 week
The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)
The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)
Measured: 1 week
The alveolar lavage fluid levels of carbohydrate antigen 125
The alveolar lavage fluid levels of carbohydrate antigen 125
Measured: 1 week
The lung tissue levels of carcinoembryonic antigen (CEA)
The lung tissue levels of carcinoembryonic antigen (CEA)
Measured: 1 week
The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)
The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)
Measured: 1 week
The lung tissue levels of carbohydrate antigen 125
The lung tissue levels of carbohydrate antigen 125
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jan 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Relationship Between the Tumor Markers and Interstitial Lung Disease PatientsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597814
- Sponsor's protocol ID
- yilunshen2020145
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Tumor Markers and Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04597814
- Acronym / sponsor ID
- yilunshen2020145
- Keywords
- carcinoembryonic antigen, carbohydrate antigen 19-9, carbohydrate antigen 125
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 22 Oct 2020 (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 serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.
This study was undertaken to investigate the source of these serum tumor markers.
Detailed description
The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.
This study was undertaken to investigate the source of these serum tumor markers.We hypothesis that these tumor markers are released from the lung.
The broncholveolr lvge fluid levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 were measured in the interstitial lung disease patients before lung transplantation. The immunohistochemical test was performed in the specimen lung after lung transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interstitial lung disease patients | – | Other: No Interventioninterstitial lung disease patients who need lung transplantation |
| non- interstitial lung disease patients | – | Other: No Interventionnon- interstitial lung disease patients who need thoracic surgery to remove pneumatocele |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung disease patients for lung transplantation
Key inclusion criteria (2 listed)
- 1.Interstitial lung disease patients for lung transplantation
- -
Key exclusion criteria (2 listed)
- tumor
- Interstitial lung disease patients could not be performed by lung transplantation
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 |
|---|---|---|
| No InterventionNo Intervention | Other | interstitial lung disease patients, non- interstitial lung disease patients |
Primary outcome
serum levels of carcinoembryonic antigen (CEA)
Time frame: 6months
serum levels of carcinoembryonic antigen (CEA)
serum levels of carbohydrate antigen 19-9 (CA19-9)
Time frame: 6months
serum levels of carbohydrate antigen 19-9 (CA19-9)
serum levels of carbohydrate antigen 125(CA125)
Time frame: 6months
serum levels of carbohydrate antigen 125(CA125)
The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)
Time frame: 1 week
The alveolar lavage fluid levels of carcinoembryonic antigen (CEA)
The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)
Time frame: 1 week
The alveolar lavage fluid levels of carbohydrate antigen 19-9 (CA19-9)
The alveolar lavage fluid levels of carbohydrate antigen 125
Time frame: 1 week
The alveolar lavage fluid levels of carbohydrate antigen 125
The lung tissue levels of carcinoembryonic antigen (CEA)
Time frame: 1 week
The lung tissue levels of carcinoembryonic antigen (CEA)
The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)
Time frame: 1 week
The lung tissue levels of carbohydrate antigen 19-9 (CA19-9)
The lung tissue levels of carbohydrate antigen 125
Time frame: 1 week
The lung tissue levels of carbohydrate antigen 125
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 23 Oct 2020.
- Individual participant dataSharing planned: Undecided
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 the Relationship Between the Tumor Markers and Interstitial Lung Disease Patients, run by The First Affiliated Hospital of Guangzhou Medical University 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 2 inclusion and 2 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 23 Oct 2020. 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?
serum levels of carcinoembryonic antigen (CEA) (time frame: 6months). The study lists 9 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 23 Oct 2020.