NCT05310604: GP-PAD II

Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.

Completed Last updated 21 February 2023

What this trial tests

trial testing Blood withdrawal in Primary Antibody Deficiencies in 104 participants. Completed in 20 February 2023.

Timeline

24 May 2022

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	UMC Utrecht
Status	Completed
Study type	OBSERVATIONAL
Enrollment	104
Start date	24 May 2022
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Blood withdrawal — full drug profile →

Conditions studied

• Primary Antibody Deficiencies — all drugs for Primary Antibody Deficiencies →

Sponsor

UMC Utrecht — full company profile →

Who can join

Adults 12 to 70, any sex, with Primary Antibody Deficiencies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous diseases. The clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. Due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity, mortality and health care costs as effective therapies are available. The currently available screening systems for the broader group of primary immunodeficiencies (PID) have been shown to have poor diagnostic performance5-10 and are time consuming. We have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for PAD. Patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of PAD. The aim of the current study is to validate this algorithm.

Objective:

Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands.

Study design: Mono-centre cohort study based on regular care data

Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of a primary care screening algorithm for the early detection of patients at risk of primary antibody deficiency.
   Messelink MA, Berbers RM, van Montfrans JM, Ellerbroek PM, et al · · 2023 · cited 11× · PMID 37245042 · DOI 10.1186/s13223-023-00790-7
2. Clinical Validation of a Primary Antibody Deficiency Screening Algorithm for Primary Care.
   Messelink MA, Welsing PMJ, Devercelli G, Marsden JWN, et al · · 2023 · cited 5× · PMID 37715890 · DOI 10.1007/s10875-023-01575-8