Primary Antibody DeficienciesGP-PAD IINCT05310604
Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.
An observational study of Primary Antibody Deficiencies, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Primary Antibody Deficiencies
- What is being tested?
- Blood withdrawal
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 May 2022to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
- Conditions
- Primary Antibody Deficiencies
- Being tested
- Blood withdrawal
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalProcedure or surgery
Single blood withdrawal for determination of immunoglobulin levels
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of high-risk patients with an eventual PAD diagnosis
Measured: measurement december 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start24 May 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Antibody DeficienciesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen L Leavis, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310604
- Sponsor's protocol ID
- NL74944.041.20
- Acronym
- GP-PAD II
- Status last verified
- Feb 2023
- First submitted
- 25 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A request for access to the IPD can be submitted, which will be reviewed by the research team.
Publications
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.
PubMed 37715890Messelink 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.
PubMed 37245042
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.
- ClinicalTrials.gov ID
- NCT05310604
- Acronym / sponsor ID
- GP-PAD II / NL74944.041.20
- Conditions
- Primary Antibody Deficiencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalSingle blood withdrawal for determination of immunoglobulin levels | Procedure or surgery | – |
Primary outcome
The percentage of high-risk patients with an eventual PAD diagnosis
Time frame: measurement december 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 37715890Messelink 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.
- Derived from this study: PubMed 37245042Messelink 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.
- Individual participant dataSharing planned: Undecided. A request for access to the IPD can be submitted, which will be reviewed by the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Antibody Deficiencies, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of high-risk patients with an eventual PAD diagnosis (time frame: measurement december 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.