Status:
ACTIVE_NOT_RECRUITING
Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Massachusetts Institute of Technology
TriNetX, LLC
Conditions:
Predictive Cancer Model
Eligibility:
All Genders
40-100 years
Brief Summary
The goal of this prospective observational cohort study is to validate previously developed Hepatocellular Carcinoma (HCC) risk prediction algorithms, the Liver Risk Computation (LIRIC) models, which ...
Detailed Description
The investigators will conduct a prospective observational cohort study, separately deploying three separate LIRIC models (the general population, cirrhosis, and no\_cirrhosis models) on retrospective...
Eligibility Criteria
Inclusion
- The investigators will utilize the following criteria for all 3 models:
- Inclusion criteria:
- Male and females age ≥40 years from all US HCOs available on the platform
- at least at least 2 clinical encounters to the HCO, within the last year, before the study start date
- Exclusion Criteria:
- Personal history of HCC or current HCC (ICD-9: 155.0; ICD-10: C22.0)
- Age below 40. The same dataset will be utilized for the non-cirrhosis validation, with exclusion of all cases with cirrhosis (ICD-9: 571.2, 571.5; ICD-10: K70, K70.3, K70.30, K70.31, K74, K74.0, K74.6, K74.60, K74.69). For the cirrhosis validation, the investigators will include only patients with the above cirrhosis codes.
Exclusion
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
6000000 Patients enrolled
Trial Details
Trial ID
NCT06140823
Start Date
April 1 2023
End Date
March 31 2027
Last Update
May 25 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115