Better Classification of Respiratory Amyloidosis | NCT05862961

Studies
Better Classification of Respiratory Amyloidosis

NCT05862961

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

May 17, 2023Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Amyloidosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Estimated

Primary Completion Date

May 15, 2025Estimated

Completion Date

May 15, 2026Estimated

First Submitted Date

Mar 27, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with respiratory amyloidosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yurdagül UZUNHAN, Pr,MD, PhD	Contact	01 48 95 52 80		yurdagul.uzunhan@aphp.fr
Magali COLOMBAT, MD PhD	Contact			Colombat.Magali@iuct-oncopole.fr

Overall Officials

Name	Affiliation	Role
Yurdagül UZUNHAN, Pr,MD, PhD	APHP Hôpital Avicenne	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000686	Amyloidosis

Ancestor Terms

ID	Term
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided