NCT06268379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2010

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

11.8 years

First QC Date

February 13, 2024

Last Update Submit

February 13, 2024

Conditions

Colon CancerModel Disease

Keywords

Colorectal cancer; Translational statistics; Online dynamic nomogram; Bayesian variable selection; Survival prediction

Outcome Measures

Primary Outcomes (2)

  • OS

    Overall Survival, time from sugary to death or last follow up

    2011-2021

  • RFS

    Relapse-free Survival, time from sugary to death or last follow up for those without relapse.

    2011-2021

Interventions

SurgeryPROCEDURE

Not an interventional study, it is an observational, longitudinal study.

Also known as: Observational study

Eligibility Criteria

Age22 Years - 101 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective study was conducted with the Cabrini Monash Colorectal Neoplasia Database 15. This prospectively maintained database includes data from both private (Cabrini) and public (The Alfred) hospitals in Melbourne, Australia. The study focused on patients who underwent surgery for colon cancer from January 2010 to December 2021.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabrini Health

Melbourne, Victoria, 3144, Australia

Location

Related Publications (5)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338RESULT

  • Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.

    PMID: 32133645RESULT

  • Jalali A, Alvarez-Iglesias A, Roshan D, Newell J. Visualising statistical models using dynamic nomograms. PLoS One. 2019 Nov 15;14(11):e0225253. doi: 10.1371/journal.pone.0225253. eCollection 2019.

    PMID: 31730633RESULT

  • Borumandnia N, Doosti H, Jalali A, Khodakarim S, Charati JY, Pourhoseingholi MA, Talebi A, Agah S. Nomogram to Predict the Overall Survival of Colorectal Cancer Patients: A Multicenter National Study. Int J Environ Res Public Health. 2021 Jul 21;18(15):7734. doi: 10.3390/ijerph18157734.

    PMID: 34360026RESULT

  • Maity AK, Basu S, Ghosh S. Bayesian Criterion Based Variable Selection. J R Stat Soc Ser C Appl Stat. 2021 Aug;70(4):835-857. doi: 10.1111/rssc.12488. Epub 2021 Aug 7.

    PMID: 38863987RESULT

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Interventions

Surgical Procedures, OperativeObservation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
11 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof Mohamad Asghari Jafarabadi

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 20, 2024

Study Start

February 15, 2010

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)