Pulmonary EmbolismNCT06017271
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
An observational study of Pulmonary Embolism and Lung Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Embolism, Lung Cancer
- What is being tested?
- CTPA (computed tomography pulmonary angiography)
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 19 Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was conducted on patients with a confirmed diagnosis of Lung Cancer who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University from 1 January 2012 to 31 December 2021. Patients who did not meet any of the inclusion criteria or met any of the exclusion criteria were excluded. The subjects were divided into PE group and control group according to the results of CTPA examination, and the patients in the two groups were matched by gender and age 1:1 tendency score.
Who may be able to join
- The pathological diagnosis was lung cancer
- Pulmonary artery was evaluated by CTA during hospitalization.
Who cannot join
- Patients with incomplete clinical data
- Patients with no follow-up data
- Patients with a history of PE before diagnosis of lung cancer
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients with lung cancer have increased inflammatory response and are more prone to suffer thrombosis. However, in lung cancer patients, the clinical correlation between EAT and pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density, as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer patients, half with pulmonary embolism and half without. The incidence of adverse prognosis and related factors were followed up by telephone.
- Conditions
- Pulmonary Embolism, Lung Cancer
- Being tested
- CTPA (computed tomography pulmonary angiography)
- Medical subject headings
- Pulmonary Embolism, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTPA (computed tomography pulmonary angiography)Diagnostic test
The CTPA diagnosis suggest or did not suggest pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| PE group | The CTPA diagnosis suggest pulmonary embolism Receives: Diagnostic Test: CTPA (computed tomography pulmonary angiography) | |
| control group | The CTPA diagnosis did not suggest pulmonary embolism Receives: Diagnostic Test: CTPA (computed tomography pulmonary angiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EAT volume
volume of epicardial adipose tissue (EAT), Cm3
Measured: May, 20, 2023
EAT density
density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)
Measured: May, 20, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 May 2024
- Primary completion15 Jul 2024
- Study completion19 Jul 2024
Why it stopped: The number of patients is not sufficient to support the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Study director, First Affiliated Hospital Xi'an Jiaotong UniversityHaichen Wang, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017271
- Sponsor's protocol ID
- XJTU1AF2023LSK-269
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2023
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT06017271
- Acronym / sponsor ID
- XJTU1AF2023LSK-269
- Conditions
- Pulmonary Embolism, Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The number of patients is not sufficient to support the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 30 Aug 2023 (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 occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients with lung cancer have increased inflammatory response and are more prone to suffer thrombosis. However, in lung cancer patients, the clinical correlation between EAT and pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density, as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer patients, half with pulmonary embolism and half without. The incidence of adverse prognosis and related factors were followed up by telephone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE group | – | Diagnostic Test: CTPA (computed tomography pulmonary angiography)The CTPA diagnosis suggest pulmonary embolism |
| control group | – | Diagnostic Test: CTPA (computed tomography pulmonary angiography)The CTPA diagnosis did not suggest pulmonary embolism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted on patients with a confirmed diagnosis of Lung Cancer who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University from 1 January 2012 to 31 December 2021. Patients who did not meet any of the inclusion criteria or met any of the exclusion criteria were excluded. The subjects were divided into PE group and control group according to the results of CTPA examination, and the patients in the two groups were matched by gender and age 1:1 tendency score.
Key inclusion criteria (2 listed)
- The pathological diagnosis was lung cancer
- Pulmonary artery was evaluated by CTA during hospitalization.
Key exclusion criteria (3 listed)
- Patients with incomplete clinical data
- Patients with no follow-up data
- Patients with a history of PE before diagnosis of lung cancer
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 |
|---|---|---|
| CTPA (computed tomography pulmonary angiography)The CTPA diagnosis suggest or did not suggest pulmonary embolism. | Diagnostic test | PE group, control group |
Primary outcome
EAT volume
Time frame: May, 20, 2023
volume of epicardial adipose tissue (EAT), Cm3
EAT density
Time frame: May, 20, 2023
density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yang Yan study director
First Affiliated Hospital Xi'an Jiaotong University
Haichen Wang principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Pulmonary Embolism and Lung Cancer, run by First Affiliated Hospital Xi'an Jiaotong 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 3 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: withdrawn, as of the sponsor's last update on 22 Jul 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
EAT volume (time frame: May, 20, 2023). The study lists 2 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 Jul 2024.