Clincosm LogoSign in Get a demo

B-AR: Better Classification of Respiratory Amyloidosis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862961
Collaborator
(none)
70
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The B-AR project is based on a retrospective analysis of amyloidosis typing and the identification of their amylogenic protein.This work should be able to unite many clinicians, including pulmonologists and pathologists around a rare disease that still suffers from insufficient data.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The B-AR study will highlight the interest of proteomic analysis of amyloidosis compared to their identification by immunostaining. The objective is to reduce diagnostic wandering and to improve patient management. The typing of respiratory amyloidosis will allow a better characterization of the disease and thus, to propose a dedicated therapeutic management.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Towards a Better Classification of Respiratory Amyloidosis. Contribution of Proteomic Analysis Based on Tandem Mass Spectrometry
    Anticipated Study Start Date :
    May 15, 2023
    Anticipated Primary Completion Date :
    May 15, 2025
    Anticipated Study Completion Date :
    May 15, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of cases with identification of the amylogenic protein in respiratory amyloidosis. [1 day (at inclusion)]

      Identification of amylogenic protein by Proteomic Analysis Based on Tandem Mass Spectrometry on histological sample of the tracheobronchial or pulmonary tree.

    Secondary Outcome Measures

    1. Distribution and severity of amyloidosis [1 day (at inclusion)]

      association between typing and respiratory involvement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patient > to 18 years with amyloidosis on a histological sample of the tracheobronchial or pulmonary tree.
    Exclusion Criteria:

    • Subject receiving state medical aid

    • Subject deprived of freedom, or under a legal protective measure (example: patients under guardianship or curators)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Study Director: Yurdagül UZUNHAN, Pr,MD, PhD, APHP Hôpital Avicenne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05862961
    Other Study ID Numbers:
    • APHP220270
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    respiratory amyloidosis
    proteomic analysis
    Additional relevant MeSH terms:
    Amyloidosis

    Study Results

    No Results Posted as of May 17, 2023