NCT05816902

Brief Summary

Background: To assist clinicians with diagnosis and optimal treatment decision-making, we attempted to develop and validate an artificial intelligence prediction model for lung metastasis (LM) in colorectal cancer (CRC) patients. Method: The clinicopathological characteristics of 46037 CRC patients from the Surveillance, Epidemiology, and End Results (SEER) database and 2779 CRC patients from a multi-center external validation set were collected retrospectively. After feature selection by univariate and multivariate analyses, six machine learning (ML) models, including logistic regression, K-nearest neighbor, support vector machine, decision tree, random forest, and balanced random forest (BRF), were developed and validated for the LM prediction. The optimization model with best performance was compared to the clinical predictor. In addition, stratified LM patients by risk score were utilized for survival analysis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,779

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

April 5, 2023

Last Update Submit

April 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung metastasis

    diagnosed with lung metastasis

    through study completion, an average of 3 month

Study Arms (2)

validation set 1

The validation set 1 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College.

Other: The location of the patient's treatment

validation set 2

The validation set 2 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Second Affiliated Hospital of Harbin Medical University.

Other: The location of the patient's treatment

Interventions

The location of the patient's treatment

validation set 1validation set 2

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with pathologic confirmation of a primary CRC diagnosis

You may qualify if:

  • patients with pathologic confirmation of a primary CRC diagnosis

You may not qualify if:

  • (1) patients with multiple primary cancers or other malignancies; (2) patients identified via autopsy or death certificate; and (3) patients with uncertain clinical data values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 18, 2023

Record last verified: 2023-04