The Distribution of Immunoglobulin Isotype in Polyclonal... | NCT06054373

Studies
The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

NCT06054373

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Jul 10, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Polyclonal Hypergammaglobulinemia
Autoimmune Diseases

Interventions

Not provided

Countries

France

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2023Actual

Primary Completion Date

Aug 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Sep 19, 2023

First Submission Date that Met QC Criteria

Sep 19, 2023

First Posted Date

Sep 26, 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

Jul 9, 2024

Last Update Posted Date

Jul 10, 2024Actual

Name	Class
Binding site	UNKNOWN

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

Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distribution of immunoglobulin isotypes	distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia associated with autoimmune and systemic diseases (systemic lupus erythematosus, rheumatoid arthritis, Gougerot-Sjögren syndrome, sarcoidosis)	one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients > 18 years old
patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

Exclusion Criteria:

Age < 18 years;
chronic viral hepatitis;
HIV infection, syphilis,
tuberculosis

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 diagnosis of various autoimmune diseases and polyclonal hypergammaglobulinaemia. Medical records from 2004 to 2018 were reviewed to identify eligible patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valéry Salle, MD	Contact	03 22 66 82 30		salle.valery@chu-amiens.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens	Recruiting	Amiens		80054	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided