AzTrials
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Colon CancerNCT06268379

BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC

An observational study of Colon Cancer and Model Disease, run by Cabrini Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 22 to 101 years
Conditions the study is for
Colon Cancer, Model Disease
What is being tested?
Surgery
Type of treatment
Surgery or procedure
How many people
2,475 participants
Where
1 siteAustralia
Study dates
15 Feb 2010to 15 Dec 2021
How long will I take part?
11 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 101 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Cabrini Health

    Melbourne, Victoria, 3144

Other trials in Australia

About this study

Official title: Developing a Clinician-friendly Online Tool for Survival Prediction in Colon Cancer Patients: A Bayesian Model Averaging for Risk Factor Selection and Dynamic Nomogram

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.

Read the 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.

Being tested
Surgery
Keywords
Colorectal cancer; Translational statistics; Online dynamic nomogram; Bayesian variable selection; Survival prediction
Medical subject headings
Colonic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Also called Observational study

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

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

    Measured: 2011-2021

  2. RFS

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

    Measured: 2011-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start15 Feb 2010
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,475 participants (actual)
Target duration
11 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268379
Sponsor's protocol ID
#08-01-03-23
Status last verified
Feb 2024
First submitted
13 Feb 2024
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33538338

  • 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.

    PubMed 32133645

  • 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.

    PubMed 31730633

  • 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.

    PubMed 34360026

  • 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.

    PubMed 38863987

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Cancer and Model Disease, run by Cabrini Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: 2011-2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268379, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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