BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC

Completed

• Conditions: Colon Cancer; Model Disease

• Registration Number: NCT06268379
• Lead Sponsor: Cabrini Health

Brief Summary

This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram.

Detailed Description

Translational statistics merges biostatistics and clinical research to communicate research findings effectively. Nomograms, graphical representations integrating independent prognostic factors, are valuable tools in colorectal cancer (CRC) research. Bayesian models for variable selection in survival outcome prediction offer advantages through Bayesian model averaging (BMA). This study aimed to utilise BMA for variable selection and develop a clinician-friendly online dynamic nomogram for survival prediction.

A retrospective study utilised the Cabrini Monash colorectal neoplasia database, including colon cancer patients who underwent surgery. Data on demographics, perioperative risks, treatment details, mortality, morbidity, and survival were collected. BMA was employed for Bayesian variable selection to identify effective risk factors for survival prediction. Sensitivity analyses using Cox-LASSO and imputation of missing data were performed. Prognostic online dynamic nomograms were constructed using selected risk factors and the R-package DynNom.

Study Timeline

• Study Start: 2010-02-15
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2475

Inclusion Criteria

In this study, patients were included based on specific selection criteria: being 18 years old or older, having a diagnosis of colon adenocarcinoma (or post polypectomy of the same condition), and having undergone surgery for colon cancer.

Exclusion Criteria

Patients with rectal cancer, neuroendocrine tumours, lymphomas and those who underwent trans-anal surgery were not included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RFS	2011-2021	Relapse-free Survival, time from sugary to death or last follow up for those without relapse.
OS	2011-2021	Overall Survival, time from sugary to death or last follow up

Trial Locations

Locations (1)

Cabrini Health; 🇦🇺 Melbourne, Victoria, Australia