- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06102278
ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture
October 25, 2023 updated by: Chen Xiaoping
Machine Learning Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture
This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis.
Clinical data from 522 patients with ruptured HCC who underwent surgery at seven different medical centers were collected and analyzed.
Machine learning models were employed for analysis and prediction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
522
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
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
522 rHCC patients who underwent radical hepatectomy
Description
Inclusion Criteria:(1) HCC confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) R0 resection (4) first tumor detection -
Exclusion Criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Training cohort
All cases were randomly grouped according to 7:3, with 70% defined as the training group
|
Patients experiencing postoperative peritoneal metastasis
|
Validation cohort
All cases were randomly grouped according to 7:3, with 30% defined as the validation group
|
Patients experiencing postoperative peritoneal metastasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2018-2023
|
Overall survival (OS) was defined as the time from the date of surgery to death
|
2018-2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2020
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
October 22, 2023
First Submitted That Met QC Criteria
October 25, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Neoplastic Processes
- Carcinoma, Hepatocellular
- Neoplasm Metastasis
- Rupture
Other Study ID Numbers
- PM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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