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Persons with electronic health records suggestive of Gaucher disease for Gaucher Disease

N/A

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial is divided into three phases. In Phase I, a screening algorithm will be used to identify patients who may have Gaucher disease. The top 50 patients from each healthcare system will be moved

Who is the study for?

This trial is for people who might have Gaucher disease, as suggested by a new algorithm analyzing their health records. It's open to anyone in the system but focuses on the top-ranked individuals based on recent healthcare interactions. To move into diagnostic testing, participants must not already be diagnosed with Gaucher or similar diseases and must consent to participate.Check my eligibility

What is being tested?

The study tests a screening tool designed to sift through electronic health records and flag potential cases of Gaucher disease. Identified individuals will then undergo retrospective medical record reviews and prospective blood tests for confirmation of the diagnosis.See study design

What are the potential side effects?

Since this trial involves diagnostic procedures rather than treatment interventions, there are no direct side effects from medications being tested. However, standard risks associated with blood draws may apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of persons with GD (including those with GD identified in Phase II and those previously undiagnosed who subsequently test positive for GD in Phase III) out of all persons highly ranked by the RDA

The proportion of previously undiagnosed persons highly ranked by RDA who subsequently test positive for GD out of persons with GD identified in Phase II and III

Secondary outcome measures

Characteristics include demographic information, alternative and concomitant diagnoses, treatments, and patterns of provider visits for the previously listed subgroups

Relationship between RDA scores and the diagnostic yield; descriptive analyses including confusion matrices

Trial Design

1Treatment groups

Experimental Treatment

Group I: Persons with electronic health records suggestive of Gaucher diseaseExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,875 Total Patients Enrolled

13 Trials studying Gaucher Disease

6,885 Patients Enrolled for Gaucher Disease

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,733 Total Patients Enrolled

10 Trials studying Gaucher Disease

872 Patients Enrolled for Gaucher Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this study at the moment?

"Indeed, according to the information provided by clinicaltrials.gov, this study is currently in the recruitment phase. The initial posting of the trial was on January 19th, 2024, and it has been recently updated on December 27th, 2023."

Answered by AI

What is the current patient population enrolled in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this particular study is currently seeking eligible participants. The trial was initially posted on January 19th, 2024 and its most recent update occurred on December 27th, 2023. To complete the trial successfully, a total of 105 individuals will be recruited from three distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation and Evaluation of a Rare Disease Algorithm to Identify Persons at Risk of Gaucher Disease Using Data From Electronic Health Records (EHRs) in the United States (Project Searchlight)

2024. "Implementation and Evaluation of a Rare Disease Algorithm to Identify Persons at Risk of Gaucher Disease Using Data From Electronic Health Records (EHRs) in the United States (Project Searchlight)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05908656.

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