NCT05862961

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

May 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 27, 2023

Last Update Submit

May 15, 2023

Conditions

Keywords

respiratory amyloidosisproteomic analysis

Outcome Measures

Primary Outcomes (1)

  • Number of cases with identification of the amylogenic protein in respiratory amyloidosis.

    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 Outcomes (1)

  • Distribution and severity of amyloidosis

    1 day (at inclusion)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with respiratory amyloidosis

You may qualify if:

  • Adult patient \> to 18 years with amyloidosis on a histological sample of the tracheobronchial or pulmonary tree.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

fixed tissue (Lung biopsy, Bronchial biopsy; trans-thoracic lung biopsy, trans-bronchial lung biopsy).

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yurdagül UZUNHAN, Pr,MD, PhD

    APHP Hôpital Avicenne

    STUDY DIRECTOR

Central Study Contacts

Yurdagül UZUNHAN, Pr,MD, PhD

CONTACT

Magali COLOMBAT, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

May 17, 2023

Study Start

May 15, 2023

Primary Completion

May 15, 2025

Study Completion

May 15, 2026

Last Updated

May 17, 2023

Record last verified: 2023-03