NCT06791486

Brief Summary

This is a multi-center, retrospective clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for predicting biological age using electronic health records (EHR). The study will analyze various health data points, including medical history, laboratory results, and clinical observations, to estimate the biological age of patients. By comparing biological age with chronological age, the study aims to assess the accuracy of the model and its potential in identifying age-related health risks and improving patient care.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

January 19, 2025

Last Update Submit

April 1, 2025

Conditions

Keywords

Biological Ageelectronic health recordsAI predictionaging

Outcome Measures

Primary Outcomes (1)

  • Biological Age Prediction Accuracy

    The accuracy of the AI model in predicting biological age compared to chronological age. This will be evaluated using the Pearson Correlation Coefficient (PCC) to assess the strength of the correlation between predicted biological age and chronological age. Additionally, R-squared (R²) will be used to evaluate the proportion of variance in biological age explained by the model.

    1 year

Secondary Outcomes (1)

  • Health Risk Correlation

    1 year

Study Arms (2)

Biologically Younger Group

Participants whose biological age is predicted to be younger than their chronological age.

Other: AI-assisted predictive model

Biologically Older Group

Participants whose biological age is predicted to be older than their chronological age.

Other: AI-assisted predictive model

Interventions

This study utilizes an AI-assisted predictive model that analyzes multimodal data from electronic health records, including medical history, laboratory results, imaging data, and lifestyle factors, to estimate biological age. The model employs deep learning algorithms to predict biological age, compare it to chronological age, and identify early signs of age-related health risks. The intervention is not a direct treatment or procedure but aims to develop a tool for predicting biological age to help personalize care and improve long-term health outcomes.

Biologically Older GroupBiologically Younger Group

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of individuals who have received care at participating hospitals or healthcare centers with accessible electronic health records (EHR). Participants will include those with complete EHR data, including medical history, laboratory test results, imaging data, and lifestyle factors such as diet, physical activity, and smoking habits. The cohort will comprise both individuals who are healthy and those with chronic conditions or comorbidities to analyze biological age prediction across different health statuses. The study will be conducted across multiple healthcare facilities to ensure a diverse patient population representing a wide range of age groups, health conditions, and demographics.

You may qualify if:

  • Patients with comprehensive and accessible EHR data, including medical history, laboratory results, treatment data, imaging data (if available), and lifestyle factors (e.g., smoking, physical activity, diet).
  • Patients with no significant cognitive impairments that would prevent them from providing informed consent or participating in the study.
  • All participants must provide informed consent for the use of their medical data for research purposes.

You may not qualify if:

  • Patients with incomplete or missing critical EHR data such as medical history, laboratory results, or treatment data that are necessary for predicting biological age.
  • atients with severe cognitive disorders (e.g., dementia, significant mental disabilities) who are unable to provide informed consent or participate meaningfully in the study.
  • Patients with terminal illnesses or those with limited life expectancy where biological age predictions may not be relevant for the purposes of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Scientist

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

March 1, 2023

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations