- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771947
Predicting Symptom Trajectories After Thoracoscopic Lung Cancer Surgery Using an Interpretable Machine Learning Model
January 8, 2025 updated by: GuiBin Qiao, Guangdong Provincial People's Hospital
Patients suffer from a variety of symptoms after thoracoscopic surgery.
However, there is a lack of validated predictive tools to identify potentially high-risk patients.
This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery.
Latent class mixed modeling (LCMM) will be used to dentify subgroups of patients with similar symptom trajectories.
Machine learning models were developed to predict postoperative symptom trajectories based on collected information.
Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Thoracoscopic lung cancer surgery is a widely utilized approach for treating early and locally advanced lung cancer.
Despite the advantages of thoracoscopic surgery, such as minimal invasion and rapid recovery, patients still suffer from a variety of symptoms such as pain, shortness of breath, sleep disorders or fatigue after surgery, which seriously affects the quality of life.
However, there is a lack of validated predictive tools to identify potentially high-risk patients.
This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery.
Patients are invited to fill out the MD Anderson Symptom Inventory-Lung Cancer module after thoracoscopic surgery.
Symptoms of interest include pain, shortness of breath, sleep disturbance, and fatigue.
Moderate to severe symptoms were defined as a score of ≥ 4. Latent class mixed modeling (LCMM), a clustering technique, can identify subgroups of patients with similar symptom trajectories based on longitudinal patient-reported outcome (PRO) data.
Machine learning models were developed to predict postoperative symptom trajectories based on collected information including demographic and clinical information, and operative data.
The machine learning models mainly include Random Forest, Support Vector Machines, Neural Networks, XGBoost, etc.
The most appropriate model is selected, and model interpretation is performed using the SHAP method.
Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guibin Qiao, MD
- Phone Number: 13602749153
- Email: guibinqiao@126.com
Study Locations
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Guangdong, China, 510080
- Guangdong Provincial People's Hospital
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Contact:
- Guibin Qiao
- Phone Number: 13602749153
- Email: guibinqiao@126.com
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Contact:
- Zijie Li
- Phone Number: 13433747658
- Email: zijie_li10@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Lung cancer patient underwent thoracoscopic surgery and completed the MD Anderson Symptom Inventory-Lung Cancer module postoperatively.
Description
Inclusion Criteria:
- Age 18-80 years old;
- Pathologically diagnosed lung cancer;
- Undergo thoracoscopic surgery, including video-assisted thoracoscopy and robotic-assisted thoracoscopic surgery;
- no prior history of malignancy or lung surgery;
- Have the ability to complete the scale.
Exclusion Criteria:
- Converted to thoracotomy during thoracoscopic surgery;
- Unable to complete the postoperative scale at least two times;
- Missing data values exceeding 30 percent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom trajectories after thoracoscopic surgery
Time Frame: Within four weeks after thoracoscopic surgery
|
Postoperative symptoms of interest included pain, shortness of breath, sleep disturbances, and fatigue.
|
Within four weeks after thoracoscopic surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guibin Qiao, Guangdong Provincial People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
January 8, 2025
First Submitted That Met QC Criteria
January 8, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 8, 2025
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC-ML
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.