Differential EBI2 Expression Upon Allelic Status of the r... | NCT03633409

Studies
Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

NCT03633409

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Aug 21, 2018Actual

Enrollment

340Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Not provided

Countries

Switzerland

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Jul 2, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 16, 2018Actual

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

Aug 17, 2018

Last Update Posted Date

Aug 21, 2018Actual

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

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will test the influence of rs9557195 genoty (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes, mRNA expression of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migraton assay.

Detailed Description

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). EBI2 is a G protein coupled receptors expressed on the immune cells. EBI2 directs migration and activity of immune cells.

Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will recruit patients with Crohn's disease and ulcerative colitis, assess epidemiological and clinical parameters (including clinical activity of IBD) draw blood, isolate lymphocytes, DNA and RNA.

The investigators will test the influence of rs9557195 genotype (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes (by FACS using an EBI2-antibody), mRNA expression (by qPCR) of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migration assay.

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

340Estimated

Label	Type	Description	Intervention Names
IBD patients and healthy volunteers		We will recruit IBD patients and healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EBI2 expression - dependent on rs9557195 allele status (FACS)	EBI2 levels in PBMCs will be determined by FACS, and compared according to allele status of rs9557195	at time of inclusion into the study

Secondary Outcomes

Measure	Description	Time Frame
EBI2 expression - dependent on rs9557195 allele status (RT-PCR)	EBI2 levels in PBMCs will be determined by RT-PCR, and compared according to EBI2 levels in PBMCs will be determined by RT-PCR, and compared according to allele status of rs9557195	at time of inclusion into the study
UBAC2 expression - dependent on rs9557195 allele status (RT-PCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with IBD OR healthy volunteer
No major uncontrolled medical/ surgical/ psychiatric condition requiring ongoing management besides IBD in the respective study groups. Well controlled conditions (i.e. medically controlled arterial hypertension, occupational asthma) may be present

Exclusion Criteria: none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

we will recruit a mixed population (patients can be in more than one group)

up to 100 healthy volunteers
up to 30 IBD patients with the rs9557195-CC IBD risk genotype in clinical remission
up to 30 IBD patients with the rs9557195-CT IBD risk genotype in clinical remission
up to 30 IBD patients with the rs9557195-TT IBD low risk genotype in clinical remission
up to 50 IBD patients of any genotype during a flare
up to 50 IBD patients of any genotype treated with vedolizumab
up to 50 IBD patients of any genotype treated with a TNF-inhibitor (infliximab, adalimumab, golimumab, certolizumab)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Misselwitz, MD	Contact	+41 44 255 1111		benjamin.misselwitz@usz.ch
Rene Roth, MD	Contact	+41 44 255 1111		rene.roth@usz.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

some of the outcome measures (EBI2 expression, cell motility assays) will be performed by external collaborators

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided