Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT05310604
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of high-risk patients with an eventual PAD diagnosis', 'timeFrame': 'measurement december 2022'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Antibody Deficiencies']}, 'referencesModule': {'references': [{'pmid': '37715890', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37245042', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nObjective:\n\nMain objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands.\n\nStudy design: Mono-centre cohort study based on regular care data\n\nStudy population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 12 and 70 years\n* A total algorithm score that is within the highest 0.66% of the algorithm scores within a single general practitioner's clinic\n* Signed informed consent\n* Did not meet exclusion criteria during manual evaluation of the health care record\n\nExclusion Criteria:\n\n* Secondary causes of immunodeficiency as registered by ICPC codes for: multiple myeloma, HIV-infection, anorexia nervosa, bulimia, cystic fibrosis.\n* 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."}, 'identificationModule': {'nctId': 'NCT05310604', 'acronym': 'GP-PAD II', 'briefTitle': 'Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.', 'orgStudyIdInfo': {'id': 'NL74944.041.20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood withdrawal', 'type': 'PROCEDURE', 'description': 'Single blood withdrawal for determination of immunoglobulin levels'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A request for access to the IPD can be submitted, which will be reviewed by the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Immunologist (MD, PhD)', 'investigatorFullName': 'Helen L Leavis', 'investigatorAffiliation': 'UMC Utrecht'}}}}