- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439991
Study of Risk Factors and Prediction of Blood Clots After Lung Cancer Surgery
Prospective Cohort Study on Risk Factors and Machine Learning-Based Prediction of Postoperative Venous Thromboembolism in Patients Undergoing Lung Cancer Surgery
The goal of this observational study is to learn about the risk factors and prediction of postoperative venous thromboembolism (VTE) in patients undergoing lung cancer surgery. The main question it aims to answer is:
Which clinical, surgical, and laboratory factors are associated with the development of postoperative deep vein thrombosis (DVT) in lung cancer surgery patients, and can machine learning models accurately predict individual risk?
Participants undergoing lung cancer surgery will be prospectively followed for 30 days after surgery. Perioperative clinical data, laboratory results, and imaging findings will be collected to identify VTE risk factors and to develop a predictive model.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wei Liu
- Phone Number: 86-13596083366
- Email: l_w01@jlu.edu.cn
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Recruiting
- The First Hospital of Jilin University, Department of Thoracic Surgery
-
Contact:
- Wei Liu
- Phone Number: 86-13596083366
- Email: l_w01@jlu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patients undergoing surgical resection for lung cancer
- Postoperative hospital stay ≥ 48 hours
- Availability of perioperative clinical, laboratory, and imaging data
- Willingness to provide informed consent and participate in 30-day follow-up
Exclusion Criteria:
- Pre-existing deep vein thrombosis (DVT) or pulmonary embolism (PE) before surgery
- Preoperative or ongoing anticoagulation therapy for ≥ 2 weeks
- Severe coagulation disorders or bleeding diseases
- Severe hepatic, renal, or hematologic dysfunction, or uncontrolled systemic infection
- Concurrent major organ surgery (e.g., cardiac, liver surgery)
- Pregnancy or lactation
- Incomplete postoperative follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
VTE Group
Adult patients undergoing lung cancer surgery who develop postoperative deep vein thrombosis (DVT) within 30 days.
Perioperative clinical, laboratory, and imaging data will be collected to identify risk factors and build predictive models.
|
The intervention involves the prospective collection of perioperative clinical, laboratory, and imaging data from adult patients undergoing lung cancer surgery.
No therapeutic or diagnostic procedures beyond standard care are applied.
Collected data will be used to identify risk factors for postoperative deep vein thrombosis (DVT) and to develop machine learning-based predictive models.
|
|
Non-VTE Group
Adult patients undergoing lung cancer surgery who do not develop postoperative DVT within 30 days.
Perioperative clinical, laboratory, and imaging data will be collected for comparison with the VTE group.
|
The intervention involves the prospective collection of perioperative clinical, laboratory, and imaging data from adult patients undergoing lung cancer surgery.
No therapeutic or diagnostic procedures beyond standard care are applied.
Collected data will be used to identify risk factors for postoperative deep vein thrombosis (DVT) and to develop machine learning-based predictive models.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative deep vein thrombosis (DVT) in lung cancer surgery patients
Time Frame: From the day of lung cancer surgery to 30 days postoperatively
|
The primary outcome is the occurrence of postoperative deep vein thrombosis (DVT) within 30 days after lung cancer surgery, confirmed by Doppler ultrasound of the lower extremities.
Perioperative clinical, laboratory, and imaging variables will be collected prospectively and analyzed to identify risk factors and develop machine learning-based predictive models for individual DVT risk.
|
From the day of lung cancer surgery to 30 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of perioperative risk factors for postoperative deep vein thrombosis (DVT) in lung cancer surgery patients
Time Frame: From the day of surgery to 30 days postoperatively
|
Secondary outcomes include the evaluation of clinical, surgical, and laboratory variables associated with postoperative DVT within 30 days.
Variables such as age, sex, BMI, comorbidities, tumor characteristics, operative details, and perioperative laboratory results will be analyzed using multivariate logistic regression and machine learning models to identify independent predictors of DVT.
|
From the day of surgery to 30 days postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Embolism and Thrombosis
- Thromboembolism
- Thrombosis
- Pathological Conditions, Signs and Symptoms
- Lung Neoplasms
- Venous Thrombosis
- Disease
- Venous Thromboembolism
Other Study ID Numbers
- JLUThorSurg-VTE02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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