Early Detection of Primary Antibody Deficiencies in Prima... | NCT05310604

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2022Actual

Primary Completion Date

Feb 20, 2023Actual

Completion Date

Feb 20, 2023Actual

First Submitted Date

Mar 25, 2022

First Submission Date that Met QC Criteria

Mar 25, 2022

First Posted Date

Apr 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2023

Last Update Posted Date

Feb 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helen L Leavis, Principal Investigator, Clinical Immunologist (MD, PhD), UMC UtrechtPrincipal Investigator

Lead Sponsor

UMC UtrechtOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood withdrawal	Procedure	Single blood withdrawal for determination of immunoglobulin levels

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of high-risk patients with an eventual PAD diagnosis		measurement december 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 12 and 70 years
A total algorithm score that is within the highest 0.66% of the algorithm scores within a single general practitioner's clinic
Signed informed consent
Did not meet exclusion criteria during manual evaluation of the health care record

Exclusion Criteria:

Secondary causes of immunodeficiency as registered by ICPC codes for: multiple myeloma, HIV-infection, anorexia nervosa, bulimia, cystic fibrosis.
The presence of one of the following during manual screening of the health care record: nephrotic syndrome, current systemic chemotherapy and stage 3-4 liver cirrhosis will be excluded. This could not be done by the algorithm as there is no ICPC code available.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Utrecht		Utrecht			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37715890	Derived	Messelink MA, Welsing PMJ, Devercelli G, Marsden JWN, Leavis HL. Clinical Validation of a Primary Antibody Deficiency Screening Algorithm for Primary Care. J Clin Immunol. 2023 Nov;43(8):2022-2032. doi: 10.1007/s10875-023-01575-8. Epub 2023 Sep 16.
37245042	Derived	Messelink MA, Berbers RM, van Montfrans JM, Ellerbroek PM, Gladiator A, Welsing PMJ, Leavis H. Development of a primary care screening algorithm for the early detection of patients at risk of primary antibody deficiency. Allergy Asthma Clin Immunol. 2023 May 27;19(1):44. doi: 10.1186/s13223-023-00790-7.

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases