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Completed

NCT Number: NCT07351708

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

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Local recurrence

    Time frame: From date of randomization until the date of death from local recurrence, assessed up to 120 months

    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.

Sponsors and collaborators

Lead sponsor

Cai Zerong

Other

Registry information

Acronym: PROMISE model

Important dates

Study start
2010
Primary completion
2022
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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