Development and Validation of a Post-operative Risk Of Local Recurrence Model Integrating Serology and Evalution (PROMISE) in Local Advanced Rectal Cancer Receiving Neoadjuvant Therapy: a Multicenter Study (PROMISE model)

Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing neoadjuvant therapy followed by total mesorectal excision.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Rectal Cancer (LARC)

Detailed Description

To address the gap in accessible and integrative risk prediction, this study aimed to develop and validate an interpretable machine learning model for the early prediction of postoperative local recurrence in LARC patients using a multicenter cohort. We employed SHapley Additive exPlanations (SHAP) analysis to elucidate feature importance and provide clear interpretations for individual predictions, with the ultimate goal of evaluating the model's clinical utility in guiding personalized patient management-particularly by identifying high-risk patients in clinical practice and informing tailored follow-up and treatment strategies to improve patient outcomes.

• Study Type: Observational
• Enrollment (Actual): 2315

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eight hundred and sixty-nine patients (median [interquartile range] age, 57 [48, 64] years; 70% [611/869] male) with LARC between January 2010 and December 2022 in SYSU6H served as the training cohort, while 1446 patients with LARC between January 2010 and December 2022 in CHH (median age, 62 [54, 69]; 62% [902/1446] male) were served as the validation cohort.

Description

Inclusion Criteria:

1. Diagnosed cT>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan;
2. Pathological proved primary rectal adenocarcinoma;
3. Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery;
4. Recieved radical tumor resection by TME surgery.

Exclusion Criteria:

1. Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery;
2. Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection);
3. Patients who died due to intra- or post-operative complications;
4. Patient who die or relapse within 30 days after surgery;
5. Patients who had a prior history of malignancy within 5 years before surgery;
6. Patients who were loss of follow-up or had inadequate clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LR patients; Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence.
non-LR patients; Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence	Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence.	From date of randomization until the date of death from local recurrence, assessed up to 120 months

Collaborators and Investigators

• Sponsor: Cai Zerong
• Investigators: Study Director: Zerong Cai, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2010
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 2025ZSLYEC-724; No.82573589 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Please contact us by Email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No