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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07351708
Acronym
PROMISE model
Enrollment
2315
Registered
2026-01-20
Start date
2010-01-06
Completion date
2025-11-30
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Rectal Cancer (LARC)

Brief summary

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.

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.

Interventions

None listed

Sponsors

Cai Zerong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Local recurrenceFrom date of randomization until the date of death from local recurrence, assessed up to 120 monthsLocal 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.

Contacts

STUDY_DIRECTORZerong Cai, MD

Sixth Affiliated Hospital, Sun Yat-sen University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026