Better Classification of Respiratory Amyloidosis (B-AR)

May 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Towards a Better Classification of Respiratory Amyloidosis. Contribution of Proteomic Analysis Based on Tandem Mass Spectrometry

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with respiratory amyloidosis

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases with identification of the amylogenic protein in respiratory amyloidosis.
Time Frame: 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.
1 day (at inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution and severity of amyloidosis
Time Frame: 1 day (at inclusion)
association between typing and respiratory involvement
1 day (at inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

May 15, 2025

Study Completion (Anticipated)

May 15, 2026

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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