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)

Cai Zerong

Status: Completed

Conditions: Locally Advanced Rectal Cancer (LARC)

Study type: Observational

Funder types: Other

Identifiers

NCT07351708

No.82573589 (Other Grant/Funding Number)

2025ZSLYEC-724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,315 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,315 participants in 2 patient groups

LR patients

Description:

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

Description:

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.