Early Detection of Fabry Disease

Takeda

Status: Active, not recruiting

Conditions: Fabry Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05106764

FLAGGING FD-1 (Other Identifier)

TAK-675-4011-1

Details and patient eligibility

About

The main aim of this study is early detection of FD using real-world data for the development of advanced natural language processing methods and to develop a predictive algorithm and to measure the performance of the algorithm in identifying participants with FD.

This study is about using data from hospital Electronic Health Record database from the last 10 years to describe the ranking of participants with FD using multilevel likelihood ratios and to validate the algorithm using positive controls. No investigational medicinal product or device will be tested in this study. Hospital electronic health record data will be analyzed for a period of up to 6 months.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• In-patient or out-patient datasets of the participating hospital in the last 10 years
• Participants at any age Positive controls: a subset of all participant hospital records that includes the participants with confirmed FD.

Trial design

50 participants in 1 patient group

Retrospective Database Analysis

Description:

Data from patient's hospital records of the last 10 years will be collected/extracted retrospectively using epidemiological methods to test the forecasting power of the algorithm.

Treatment:

Other: No intervention