MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLA... | NCT02954705

Studies
MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS

NCT02954705

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Oct 22, 2020Actual

Enrollment

63Actual

Phase

Not provided

Conditions

ANCA-associated Vasculitis

Interventions

Non interventional study

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

Oct 2020

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

Aug 28, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 2, 2016

First Posted Date

Nov 3, 2016Estimated

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

Oct 21, 2020

Last Update Posted Date

Oct 22, 2020Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Activation of neutrophils by ANCA ("Anti-Neutrophil Cytoplasm Antibodies") and subsequent microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis (AAV), a severe autoimmune disease that often targets the kidney. There is no specific treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage renal disease, requiring dialysis and kidney transplantation. In addition, there is no reliable biological marker of the disease activity available, which makes the diagnostic, follow-up and treatment of patients difficult. Therefore, the identification of new therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to improve AAV patients care and to ameliorate their renal outcome.

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

Retention

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group AAV		Patients recruited from the Nantes University Hospital. 50 milliliter of blood and 10mL of urine are collected from these patients during levies in clinical visit.	Other: Non interventional study
Group control		People recruited from the "Etablissement français du sang" (French blood establishment ). 10 milliliter of blood are collected from these donors	Other: Non interventional study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non interventional study	Other	This is a non interventional study because all levies are performed during visit planned for the care of patients.	Group AAV Group control

Measure	Description	Time Frame
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.		6 month after maintenance treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria for patients:

Adult patients aged over 18 years
Patients with Granulomatosis with polyangiitis or microscopic polyangiitis meeting the criteria of Chapel Hill.
corticosteroid treatment <20 mg / day.
Informed consent: oral for participation in research and writing for biological collection.

Inclusion Criteria for controls patients:

- healthy-topics matched for age, recruited from the Etablissement français du sang or in the Department of Internal Medicine of Nantes University Hospital

Non Inclusion Criteria:

ANCA-associated vasculitis with Eosinophilic granulomatosis with polyangiitis (AAV-EGPA).
Infectious or progressive tumor pathology.
Pregnancy, lactation
Treatment with cyclophosphamide in the 6 months prior to inclusion.
Terminal chronic renal failure, presence of organ allograft.
Thrust Patients receiving corticosteroids> 20 mg / d in the previous 4 weeks.
Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)
Minor subject, under judicial protection, guardianship

Accepts Healthy Volunteers

Yes

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

This will be done in total in 50 patients with ANCA-associated vasculitis (AAV) and 20 control patients. Among the 50 patients with AAV, 30 patients will be newly diagnosed and 20 already followed for AAV

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Fadi Fakhouri, Pr	Nantes University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	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

Condition Browse Module

MeSH Terms

ID	Term
D056648	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Ancestor Terms

ID	Term
D056647	Systemic Vasculitis
D014657	Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided