Colorectal CancerNCT05816902
AI Prediction Model and Risk Stratification for Lung Metastasis in Colorectal Cancer
An observational study of Colorectal Cancer and Lung Metastases, run by Peking Union Medical College.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Lung Metastases
- What is being tested?
- The location of the patient's treatment
- How many people
- 2,779 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with pathologic confirmation of a primary CRC diagnosis
Who may be able to join
- patients with pathologic confirmation of a primary CRC diagnosis
Who cannot join
- (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
About this study
Official title: Development and Validation of an Artificial Intelligence Prediction Model and a Survival Risk Stratification for Lung Metastasis in Colorectal Cancer From Highly Imbalanced Data
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.
Read more
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.
- Conditions
- Colorectal Cancer, Lung Metastases
- Being tested
- The location of the patient's treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The location of the patient's treatmentOther
The location of the patient's treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The location of the patient's treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung metastasis
diagnosed with lung metastasis
Measured: through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Xishan Wang, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816902
- Sponsor's protocol ID
- PekingUMC02
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence Prediction Model and a Survival Risk Stratification for Lung Metastasis in Colorectal Cancer From Highly Imbalanced Data
- ClinicalTrials.gov ID
- NCT05816902
- Acronym / sponsor ID
- PekingUMC02
- Conditions
- Colorectal Cancer, Lung Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,779 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| validation set 1 | – | Other: The location of the patient's treatmentThe 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. |
| validation set 2 | – | Other: The location of the patient's treatmentThe 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with pathologic confirmation of a primary CRC diagnosis
Key inclusion criteria (1 listed)
- patients with pathologic confirmation of a primary CRC diagnosis
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The location of the patient's treatmentThe location of the patient's treatment | Other | validation set 1, validation set 2 |
Primary outcome
lung metastasis
Time frame: through study completion, an average of 3 month
diagnosed with lung metastasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lung Metastases, run by Peking Union Medical College.
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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
lung metastasis (time frame: through study completion, an average of 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.