Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 and biomarkers 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.
Primary outcome measures
- Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism [Time frame: Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months.]
Secondary outcome measures (3)
- Progression-free survival [Time frame: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.]
- Overall survival [Time frame: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.]
- Objective response rate [Time frame: From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Presence of two or more primary cancers
- Missing data for key variables
- Inability to comply with follow-up requirements
- Presence of VTE/ATE at the time of ICI initiation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- The Fourth Hospital of Inner Mongolia Autonomous Region — Hohhot
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
- Beijing Luhe Hospital, Capital Medical University — Beijing
- China-japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06950697 · CYFH202212