NCT06017271

Brief 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 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

August 24, 2023

Last Update Submit

July 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • EAT volume

    volume of epicardial adipose tissue (EAT), Cm3

    May, 20, 2023

  • EAT density

    density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)

    May, 20, 2023

Study Arms (2)

PE group

The CTPA diagnosis suggest pulmonary embolism

Diagnostic Test: CTPA (computed tomography pulmonary angiography)

control group

The CTPA diagnosis did not suggest pulmonary embolism

Diagnostic Test: CTPA (computed tomography pulmonary angiography)

Interventions

The CTPA diagnosis suggest or did not suggest pulmonary embolism.

PE groupcontrol group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • The pathological diagnosis was lung cancer
  • Pulmonary artery was evaluated by CTA during hospitalization.

You may not qualify if:

  • Patients with incomplete clinical data
  • Patients with no follow-up data
  • Patients with a history of PE before diagnosis of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Pulmonary EmbolismLung Neoplasms

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Yang Yan

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR
  • Haichen Wang

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

May 1, 2024

Primary Completion

July 15, 2024

Study Completion

July 19, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations