Circulating MicroRNAs in Understanding Pathogenesis of Sy... | NCT02756546

Studies
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

NCT02756546

Sponsor

Cairo University

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Systemic Lupus Erythematosis

Interventions

Cyclophosphamide
Hydroxychloroquine
Hydrocortisone

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

Apr 2016

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

Sep 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 26, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 29, 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

Apr 27, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mona Kortam, Teaching Assistant at faculty of Pharmacy Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

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

This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in plasma of SLE patients and difference in their expression among groups with different systemic lupus erythematosis disease activity index (SLEDAI) scores.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Healthy volunteers
Patients	Active Comparator	SLE patients further divided into mild and severe patients	Drug: Cyclophosphamide Drug: Hydroxychloroquine Drug: Hydrocortisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug		Patients
Hydroxychloroquine

Measure	Description	Time Frame
MicroRNAs expression level		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult systemic lupus erythematosis patients

Exclusion Criteria:

Patients younger than 18 years, patients with other autoimmune diseases or malignancy.

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

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide
D006886	Hydroxychloroquine
D006854	Hydrocortisone

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided