Urticaria Clinical Trial
Official title:
Angioedema Biomarker Research Study
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.
Purpose: The purpose of this prospective non-interventional non-randomized diagnostic study is to first identify patients with recurrent angioedema attacks, then collect their blood samples (venipuncture) and ultimately send the samples to specialized laboratories to perform multiple diagnostic assays, novel and traditional, that can distinguish the various forms of angioedema (urticaria and non-urticarial symptoms and signs), and healthy subjects. Methods and Materials: Blood specimen collection from a total of 300 patients with recurrent angioedema attacks, and 300 healthy volunteers without a history of angioedema attacks. Laboratory testing will include assays on multiple platforms. Complement testing via immunoassay and biochemistry techniques. Flow Cytometry using multiple markers. Mass Spectrometry that includes bradykinin metabolite and histamine detection. Molecular Genetics include Sanger sequencing, Next Generation Sequencing (NGS), and digital PCR. Patient population: Study participants to be screened who have a history of recurrent angioedema incidents as well as a population of healthy subjects. A medical history will be documented after obtaining informed patient consent to enter into the clinical trial. Each enrolled participant will have blood collected as whole blood, plasma and serum via venipuncture. Eligibility criteria (inclusion) for sample collection (angioedema subject): - Understand and sign the informed consent form before starting any study procedure. - Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian). - Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA. - Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy. Eligibility criteria (inclusion) for sample collection (for healthy participant/subject): - Understand and sign the informed consent form before starting any study procedure. - Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian). - No history of any angioedema symptoms and signs, previous laboratory diagnostic testing, or genetically proven cases. - Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy. - Not on ACE inhibitors and if on blood pressure medication, to indicate the drug(s). Exclusion Criteria (for all participants): - Minor: 11 years of age or younger. - Cannot read or understand the informed consent form and instructions. - Unable to perform the peripheral blood sample collection. - Taking medications contraindicated for testing. - History of excessive bleeding after phlebotomy, e.g. Hemophilia. - Contraindication due to other health-related issues. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03693625 -
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
|
Phase 2 | |
Recruiting |
NCT03545464 -
COrticosteroids in acUte uRticAria in emerGency dEpartment
|
Phase 3 | |
Completed |
NCT00541255 -
A Long-Term Examination of Asthma From Childhood Through Adolescence
|
||
Not yet recruiting |
NCT00163839 -
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
|
N/A | |
Terminated |
NCT00069329 -
Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease
|
N/A | |
Completed |
NCT00876369 -
Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema
|
||
Terminated |
NCT00199238 -
Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria
|
Phase 2 | |
Completed |
NCT02576041 -
Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
|
Phase 4 | |
Completed |
NCT00724698 -
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
|
||
Completed |
NCT02238249 -
Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria
|
N/A | |
Completed |
NCT00001150 -
Induction of Suction Blisters in Patients With Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers
|
N/A | |
Completed |
NCT03296358 -
Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department.
|
N/A | |
Completed |
NCT00130234 -
Effect of Anti-IgE in Chronic Urticaria
|
Phase 2 | |
Completed |
NCT00795158 -
How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
|
Phase 3 | |
Completed |
NCT00368823 -
A Trial of Point of Care Information in Ambulatory Pediatrics
|
Phase 3 | |
Completed |
NCT02424799 -
Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264
|
Phase 1 | |
Completed |
NCT01371877 -
The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment
|
N/A | |
Completed |
NCT00751218 -
A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735)
|
Phase 4 | |
Completed |
NCT03137069 -
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
|
Phase 2 | |
Recruiting |
NCT05115136 -
Using Doxepin for Urticaria
|
Phase 3 |