NCT03267875

Brief Summary

IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions. The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum. This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved. One of the conditions associated with this disease is oritis / periortitis and aneurysms

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 29, 2017

Last Update Submit

November 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • IgG4 Level

    count IgG4 Level to figure if its IgG4-related disease

    1 year

Study Arms (1)

single arm

EXPERIMENTAL

Patients after aneurysm in the aorta, Men and women aged 18-100 (not including special populations), who are able to read understand and sign a written consent to participate in the research

Procedure: Blood Test

Interventions

Blood TestPROCEDURE

draw out 2 blood tubes from a patient

single arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale and female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients after aneurysm in the aorta
  • Men and women aged 18-100 (not including special populations)
  • Those who are able to read understand and sign a written consent to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yael Eizikovits

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related DiseaseAortic Aneurysm

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Yael Eizikovits, B.A

    Meir Medical Center

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 30, 2017

Study Start

November 8, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-08

Locations