Lymphocyte Sub-populations and Auto Immune Diseases | NCT03901664

Studies
Lymphocyte Sub-populations and Auto Immune Diseases

NCT03901664

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 3, 2019Actual

Enrollment

3,500Actual

Phase

Not provided

Conditions

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Apr 1, 2018Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

Dec 4, 2018

First Submission Date that Met QC Criteria

Apr 2, 2019

First Posted Date

Apr 3, 2019Actual

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

Apr 2, 2019

Last Update Posted Date

Apr 3, 2019Actual

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

To determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

Detailed Description

The goal of this study is to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

All patients who had an evaluation of their lymphocyte subpopulations between january 2010 and december 2016 will be included in a retrospective analysis.

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

3,500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of autoimmune disease	Diagnosis (systemic lupus erythematosus, primary Sjopgren's ....) according to current ACR/EULAR criteria	an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

autoimmune or infectious disease

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

autoimmune diseases (lupus and Sjogren's) or chonic infection (Whipple's disease)

Sampling Method

Non-Probability Sample