- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267767
Comparison of Six Different Machine Learning Methods With Traditional Model for Low Anterior Resection Syndrome After Minimally Invasive Surgery for Rectal Cancer -- Development and External Validation of a Nomogram : A Dual-center Cohort Study
November 25, 2025 updated by: Daorong Wang, Northern Jiangsu People's Hospital
Following thorough screening based on inclusion and exclusion criteria, patients from the two sizable medical centers were split up into two cohorts for this study.
Cohort 1 served primarily as the training and internal validation set, while Cohort 2 was used for external validation of the predictive model constructed from Cohort 1.
We used six distinct machine learning methodss, including DT, RF, XGBOOST, SVM, lightGBM, and SHLNN, in addition to conventional logistic regression to create the predictive model.
We chose the approach with the best sensitivity and specificity by comparing the concordance index(C-index) akin to the area under the ROC curve (AUC) of these seven distinct model-building methods.
The predictive model for Cohort 1 was then built using this method, and internal validation was finished.
Lastly, Cohort 2 underwent external validation of the predictive model
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
3500
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
This retrospective analysis included 3,937 radical rectal cancer cases from two Chinese university hospitals (Northern Jiangsu People's Hospital 2015-2023, n=2612; Jilin University's China-Japan Union Hospital 2021-2023, n=1325), with rigorous selection criteria ensuring cohort homogeneity
Description
Inclusion Criteria:(1) rectal adenocarcinoma (2) minimally invasive sphincter-preserving surgery (taTME/ISR/LAR) (3) intact baseline anal function (4) no emergent presentations or metastases.
-
Exclusion Criteria:emergent presentations or metastases
-
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 |
|---|---|---|
|
low anterior resection syndrome
Time Frame: 1 and 3 months after surgery
|
1 and 3 months after surgery
|
|
|
Comparison of Six Different Machine Learning Methods With Traditional Model for Low Anterior Resection Syndrome After Minimally Invasive Surgery for Rectal Cancer -- Development and External Validation of a Nomogram : A Dual-center Cohort Study
Time Frame: 3 months
|
using LARS Score to assess the LARS situation
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
April 10, 2015
Primary Completion (Actual)
October 7, 2023
Study Completion (Actual)
June 20, 2024
Study Registration Dates
First Submitted
July 9, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Low Anterior Resection Syndrome
- Rectal Neoplasms
Other Study ID Numbers
- jiangsuNorthen20
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.
Clinical Trials on Rectal Cancer
-
Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
-
First Affiliated Hospital of Wenzhou Medical UniversityCompletedRectal Cancer Stage | Rectal Cancer PatientsChina
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
-
OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.Active, not recruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedMetastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IV Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Locally...United States
Clinical Trials on nCRT
-
Fudan UniversityShanghai Zhongshan HospitalCompletedNeoplasm, Esophagus | Neoplasm, Squamous Cell
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingRadiation-induced Intestinal Injury
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingRadiation-induced Intestinal Injury
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingRectal Neoplasm MalignantChina
-
Zhongnan HospitalNot yet recruiting
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingRadiation-induced Intestinal Injury
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNanfang Hospital of Southern Medical UniversityNot yet recruiting
-
Peking Union Medical College HospitalPeking University People's Hospital; Beijing Friendship Hospital; Cancer Institute... and other collaboratorsUnknownRectal Cancer, Adenocarcinoma | Neoadjuvant Chemoradiation
-
Heinrich-Heine University, DuesseldorfUniversity of Cologne; University Hospital, Bonn; University Hospital Tuebingen; University Hospital of Cologne and other collaboratorsCompleted
-
The First Hospital of Jilin UniversityNot yet recruitingLocally Advanced Rectal Cancer | Anti-PD-1 | Total Neoadjuvant TreatmentChina