Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders

NCT06037967 | Recruiting

• 1 other identifier: RC31/23/0173
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic diseases. The biobank will help to identify new prognostic, diagnostic and/or predictive biomarkers.

Conditions

Allergic Diseases; Asthma; Mast Cell Disorders

Keywords

Allergy; asthma; mast cell disorders; biomarkers; biobank

Outcome Measures

Primary Outcomes (1)

• Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders

  constitution of a clinico-biological biobanking

  15 years

Secondary Outcomes (6)

• set of diagnostic and/or prognostic biomarkers

  15 years

• set of predictive biomarkers

  15 years

• Allergy markers exploration

  15 years

• Estimation of concordance of biomarkers

  15 years

• Evolution of biomarkers

  15 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with respiratory disease or allergic disease or mast cell disorders

You may qualify if:

• patients with a positive prick test or specific IgE regardless of the allergen
• patients suspected of allergic pathology defined by the need to carry out a prick test or specific IgE or a food or drug reintroduction test as part of the treatment
• patients with systemic or cutaneous mastocytosis according to the international classification8
• patients with mast cell activation syndrome according to the international classification8
• patients with familial hyper-alpha tryptasemia on the presence of variation in the number of copies of the alpha allele of the TPSAB1 gene
• patients with asthma of any severity
• people affiliated or beneficiaries of a social security scheme
• patients able to receive and understand the information on the study and their participation and having freely consented to it in writing before any collection of samples or data necessary for the research (no restriction of rights by the judicial authorities and mastery of the French language).

You may not qualify if:

• patients under legal protection, guardianship or curatorship
• pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Laurent GUILLEMINAULT

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample and tumor tissues

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Laurent GUILLEMINAULT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent GUILLEMINAULT, MD

CONTACT

05 67 77 17 51; guilleminault.l@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): May 1, 2038
• Study Completion (Estimated): June 1, 2038
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

FR (1)