Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
SUMMARY

The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are: 1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 2. What are the risk factors for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors? Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Histopathologically confirmed lung cancer diagnosis at enrollment

• Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor

• Signed informed consent form

Locations
Other Locations
China
Beijing Chaoyang Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Luhe Hospital, Capital Medical University
RECRUITING
Beijing
China-japan Friendship Hospital
RECRUITING
Beijing
The Fourth Hospital of Inner Mongolia Autonomous Region
RECRUITING
Hohhot
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yuhui Zhang
zhangyhcy@163.com
86+13520108369
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 2400
Treatments
with immune checkpoint inhibitor-associated venous thromboembolism
patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
without immune checkpoint inhibitor-associated venous thromboembolism
patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
with immune checkpoint inhibitor-associated arterial thromboembolism
patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group
without immune checkpoint inhibitor-associated arterial thromboembolism
patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group
Sponsors
Collaborators: Capital Medical University, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Fourth Hospital of Inner Mongolia Autonomous Region
Leads: Beijing Chao Yang Hospital

This content was sourced from clinicaltrials.gov