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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06268379
Registration number
NCT06268379
Ethics application status
Date submitted
13/02/2024
Date registered
20/02/2024
Date last updated
20/02/2024
Titles & IDs
Public title
BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC
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Scientific 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
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Secondary ID [1]
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#08-01-03-23
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colon Cancer
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Model Disease
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Surgery
Treatment: Surgery: Surgery
Not an interventional study, it is an observational, longitudinal study.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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OS
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Assessment method [1]
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Overall Survival, time from sugary to death or last follow up
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Timepoint [1]
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2011-2021
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Primary outcome [2]
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RFS
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Assessment method [2]
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Relapse-free Survival, time from sugary to death or last follow up for those without relapse.
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Timepoint [2]
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2011-2021
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Eligibility
Key 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.
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Minimum age
22
Years
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Maximum age
101
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
Patients with rectal cancer, neuroendocrine tumours, lymphomas and those who underwent
trans-anal surgery were not included in the study.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/02/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/12/2021
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Sample size
Target
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Accrual to date
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Final
2475
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Cabrini Health - Melbourne
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Recruitment postcode(s) [1]
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3144 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Cabrini Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06268379
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06268379
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