- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06432283
A Machine Learning-based Estimated Survival Model
May 22, 2024 updated by: Zhao Siyao
Construction and Validation of a Machine Learning-based Estimated Survival Model for Elderly Patients With Advanced Malignancy
Malignant tumors are the leading cause of death in elderly patients, and palliative care can improve the quality of life for elderly advanced cancer patients.
One of the main reasons why these patients are not included in palliative care is the lack of accurate estimation of their survival period by patients, family members, and doctors.
Both doctors and patients tend to be overly optimistic about the survival period of elderly advanced cancer patients, leading to overtreatment.
Therefore, assessing the risk of death for these patients and further establishing a survival period estimation model can improve the accuracy of doctors' clinical predictions of patient survival, facilitate early referral to palliative care, and promote rationalization of medical decision-making.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
- By searching the literature, conducting systematic reviews, and meta-analyses, we aim to uncover the prognostic factors related to death in elderly advanced cancer patients.
- Based on evidence-based data and considering the clinical conditions of elderly advanced cancer patients in China, we will establish relevant entries for a risk assessment scale for death in elderly advanced cancer patients. By using the Delphi expert consultation evaluation method, we will finalize the assessment scale framework, laying the theoretical foundation for the establishment and validation of a death risk prediction model for elderly advanced cancer patients in China.
- Develop a survival estimation model for elderly advanced cancer patients; through metabolomics studies and other research methods, we will investigate metabolic biomarkers related to predicting the survival period of elderly advanced cancer patients.
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sichuan
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Chengdu, Sichuan, China, 610041
- Siyao Zhao
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Advanced cancer (stage III and IV) malignant tumor patients aged 60 years and above.
Description
Inclusion Criteria:Inclusion criteria for late-stage malignant tumor patients: Must meet Condition 1) and also meet either Condition 2), 3), or 4):
- Clinical diagnosis of advanced malignant tumor: TNM stage III or IV
- "Surprise question": If this patient were to die within the next 6 months, it would not be surprising to you.
- Karnofsky performance status (KPS) score ≤ 50
- Palliative Performance Scale (PPS) ≤ 50%
Exclusion Criteria:
- Patients who refuse to participate in the study;
- Patients who, for various reasons, are unable to cooperate and complete the questionnaire survey;
- Patients who, for various reasons, are unable to cooperate and complete the follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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advanced cancer (stage III and IV) patients aged 60 years and above.
advanced cancer (stage III and IV) patients aged 60 years and above who are receiving treatment at the mentioned institution.
The research subjects voluntarily participate and sign informed consent forms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A model
Time Frame: 2026-12-31
|
Build a survival estimation model for elderly late-stage cancer patients.
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2026-12-31
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Siyao Zhao, postgraduate, West China Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
May 15, 2024
First Submitted That Met QC Criteria
May 22, 2024
First Posted (Actual)
May 29, 2024
Study Record Updates
Last Update Posted (Actual)
May 29, 2024
Last Update Submitted That Met QC Criteria
May 22, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2024 Review (807)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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