IgG4-related DiseaseNCT03267875
A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood
A study testing Blood Test in people with IgG4-related Disease and Aortic Aneurysm, run by Meir Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- IgG4-related Disease, Aortic Aneurysm
- What is being tested?
- Blood Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Nov 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any patient who does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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
It is common to divide the aortic aneurysms according to the following etiologies:
- Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether IgG4RD is related / not related.
- Atherosclerotic infrastructure.
Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In addition, the laboratory findings are usually white counts and increased CRP.
In this context, the investigators will examine the level of IgG4 in the blood of a population of patients with aortic aneurysms and try to understand the proportion of patients whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related Disease.
the investigator chose the blood IgG4 level because it is the most important diagnostic variable for the disease (it is customary to place the incision point at > 135mg / dL).
- Conditions
- IgG4-related Disease, Aortic Aneurysm
- Being tested
- Blood Test
- Medical subject headings
- Immunoglobulin G4-Related Disease, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestProcedure or surgery
draw out 2 blood tubes from a patient
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG4 Level
count IgG4 Level to figure if its IgG4-related disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start8 Nov 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-related DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair levy, Meir Medical Center
- Investigators
- Yael Eizikovits, B.A, Study chair, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267875
- Sponsor's protocol ID
- Aneurysm-IgG4
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood
- ClinicalTrials.gov ID
- NCT03267875
- Acronym / sponsor ID
- Aneurysm-IgG4
- Conditions
- IgG4-related Disease, Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
It is common to divide the aortic aneurysms according to the following etiologies:
- Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether IgG4RD is related / not related.
- Atherosclerotic infrastructure.
Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In addition, the laboratory findings are usually white counts and increased CRP.
In this context, the investigators will examine the level of IgG4 in the blood of a population of patients with aortic aneurysms and try to understand the proportion of patients whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related Disease.
the investigator chose the blood IgG4 level because it is the most important diagnostic variable for the disease (it is customary to place the incision point at > 135mg / dL).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: Blood TestPatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any patient who does not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Testdraw out 2 blood tubes from a patient | Procedure or surgery | single arm |
Primary outcome
IgG4 Level
Time frame: 1 year
count IgG4 Level to figure if its IgG4-related disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Eizikovits, B.A study chair
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Test in people with IgG4-related Disease and Aortic Aneurysm, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Levi, EMT-P (+972-9-7471936, eran.levi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG4 Level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.