Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

NCT04963634 | Terminated

• 2 other identifiers: 2020_592020-A03306-33
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity. Biomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.

Conditions

Angio Edema

Keywords

Angioedema; Bradykinin; Biomarker; Biobanking

Outcome Measures

Primary Outcomes (1)

• compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test

  to evaluate the contribution of a plasma proteomic signature including albumin, gammaglobulin and alpha macroglobulin the plasma proteome of two group: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

  through study completion an average of 1 year

Secondary Outcomes (3)

• analyze the following biomarkers for diagnostic purposes in both groups.

  Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

• the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks

  at 1 year

• Implementation of a biobank to identify future biomarkers

  Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

Study Arms (2)

Patients with bradykinin angioedema

Other: Biobanking

Patients with histamine-mediated angioedema

Other: Biobanking

Interventions

Biobanking OTHER

For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).

Also known as: Biobanking without genetic analysis

Patients with bradykinin angioedema; Patients with histamine-mediated angioedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital

You may qualify if:

• Group 1 : Patients with bradykinin angioedema
• Patient with biologically proven hereditary angioedema with C1 inhibitor deficiency,
• Or a patient with bradykinin angioedema related to a plasminogen or factor XII mutation,
• Or patients with bradykinin angioedema related to ACE inhibitors or ARB2,
• Or patient with acquired bradykinin angioedema due to C1 inhibitor deficiency,
• Age \> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
• Having a blood collection scheduled as part of routine care
• Being insured by social security
• Group 2 : Patients with histamine-mediated angioedema
• Patient with idiopathic histamine angioedema as determined by the referring physician
• Age \> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
• Having a blood collection scheduled as part of routine care
• Being insured by social security

You may not qualify if:

• Minors or protected adults,
• Pregnant or breastfeeding woman,
• Person deprived of liberty,
• Person in an emergency situation,
• Person having refused or unable to give their non-opposition

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Angioedema

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 15, 2021
• Study Start: January 22, 2022
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)