Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05908656
Eligibility Criteria:
Inclusion Criteria:
* Phase I (Model Deployment): All persons within the EHRs of the selected IDNs will be included in this stage.
* Phase II (Case Ascertainment): The 150 to 200 persons with the highest RDA values (i.e., 50 per healthcare system) who are active (any documented interaction with the healthcare system in the previous 18 months) will be included in this stage.
* Phase III (Diagnostic Testing): The subset of persons from Phase II who: (1) have not been diagnosed with GD or ASMD, and (2) have not had GD and ASMD conclusively ruled out, will be asked to provide consent to undergo diagnostic testing. Individuals who meet these criteria and who provide written informed consent (or those whose parents/guardians provide consent as appropriate) will be included in this stage.
Exclusion Criteria:
* There are no exclusion criteria for Phase I or Phase II.
* Phase III (Diagnostic Testing):
* Patient is unable/unwilling to provide informed consent for diagnostic testing, or
* Patient is no longer under the care of the IDN
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05908656
Study Brief:
Protocol Section:
NCT05908656