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Completed

NCT Number: NCT05884060

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

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.

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Key information

Conditions

PNH Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes Thrombosis Vascular Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ≥14 years of age
  • At least 1 record encoded in the General Hospital Delta (AZ Delta) patient database (HiX) between 20 April 2018 and 1 March 2022
  • A history or presence of at least one PNH risk factors identified following retrospective screening of electronic patient records

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

No interventions

Primary outcomes

  1. PNH risk factors translation into query codes that can be interpreted by a computer system for analysis

    Time frame: 2022

    Three main PNH risk sub-cohorts were constructed, representing patients exhibiting PNH risk factors such as hemolytic anemia (group 1), bone marrow dysfunction (group 2) and thrombosis (group 3). To build these sub-cohorts, queries were created using a combination of structured and unstructured electronic health record (EHR) data, including lab results, diagnoses, medication, questionnaire data, text from medical and radiology reports, notes, and Internation Classification Codes (ICD-10). These sub-cohorts were validated by two hematologists who reviewed randomly selected patients, resulting in several iterations and query optimizations.

  2. Number of patients identified with high risk for PNH clone and per type of screening criteria by developing a computational screening algorithm

    Time frame: 2022

    A computational algorithm was employed for a retrospective EHR analysis, to identify high-risk cohorts of potential PNH patients who need treatment from all registered patients, with maximum ability to find relevant cases. Three main PNH risk sub-cohorts were constructed, representing patients exhibiting PNH risk factors such as hemolytic anemia (group 1), bone marrow dysfunction (group 2) and thrombosis (group 3). These sub-cohorts were validated by two hematologists who reviewed randomly selected patients, resulting in several iterations and query optimizations. Sub-cohorts were subsequently merged and refined into high risk cohorts that undergo further analysis and manual review. Two hematologists independently reviewed and rated medical records to achieve a manual risk stratification of the high risk cohorts.

Secondary outcomes

  1. The number of patients at high risk for PNH, categorized by risk factor, across each medical department

    Time frame: 2023

    To increase awareness of PNH risk factors by medical departments that need to consider PNH lab testing

Sponsors and collaborators

Lead sponsor

AZ Delta

Other

Collaborators

  • Alexion Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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