NCT05884060

Retrospective Chart Review Screening Algorithm to Assess the Prevalence of PNH-clones

Retrospective Electronic Chart Review to Assess the Prevalence of PNH-clones Among Patients Identified With PNH Risk Factors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 568 (actual)
• Sponsor: AZ Delta · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: —

Summary

The present study is a non-interventional retrospective chart review study assessing the prevalence of PNH-clones in patients with PNH risk-factors aged ≥14 years and treated at our hospital. The objective of this study is to develop a PNH screening tool on the hospital Electronic Health Record (EHR) system. An algorithm defining PNH risk groups is developed.

Detailed description

Paroxysmal Nocturnal Hemoglobinuria (PNH) is a life-threatening hematological disorder, but with an effective therapy. Prevalence is estimated between 1-5 per million people, often manifested by cardiovascular, gastrointestinal, neurological or haematological symptoms. Referral is therefore typically to several specialists, resulting in PNH underdiagnosis. This chart review study consists primarily of developing an algorithm to identify a high-risk cohort of potential PNH patients who need treatment from all registered patients, with maximum ability to find relevant cases. Secondly, this cohort will be manually reviewed by clinicians for final screening. The challenge hence is maximizing the ability to find all relevant PNH patients yet limiting the number to ensure manual review is possible.

Conditions

• PNH
• Thrombosis

Interventions

Type	Name	Description
OTHER	No intervention	No interventions

Timeline

• Start date: 2018-04-20
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2023-06-01
• Last updated: 2023-06-02

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study