Primary Objective The prevalence and incidence of (pre)malignant and inflammatory pathology in the gastrointestinal tract of patients with a primary antibodydeficiency (CVID, XLA, IgG subclasse deficiency and abnormal vaccinationrespons). Secondary…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence and incidence of (pre)malignant and inflammatory pathology in
the gastrointestinal tract of patients with a primary antibodydeficiency (CVID,
XLA, IgG subclasse deficiency and abnormal vaccinationrespons).
Secondary outcome
(1) Prevalence of asymptomatic carrier of bacterial, virale and/or parasitary
pathogens.
(2) Identification of subgroeps within the group of CVID patients:
determination of possible relationship with (B cel) fenotype en genotype (CVID
gerelateerde B cel mutaties) and the gastrointestinale pathology.
Background summary
An important focus of interest at the outpatient clinic of infectious diseases
of the university hospital of infectious diseases are patients with a primary
immunodeficiency.
The group of patients with a primary antibody deficiency (CVID, XLA, IgG
subclasse deficiency and abnormal vaccinationrespons) form a large portion of
this group of patients. Currently there are 73 patients and per year 10 new
patients.
The focus of this research project will be the gastrointestinal pathology in
the gastrointestinal tract of patients with a primary antibodydeficiency (CVID,
XLA, IgG subclasse deficiency and abnormal vaccinationrespons).
Study objective
Primary Objective
The prevalence and incidence of (pre)malignant and inflammatory pathology in
the gastrointestinal tract of patients with a primary antibodydeficiency (CVID,
XLA, IgG subclasse deficiency and abnormal vaccinationrespons).
Secondary Objective(s):
(1) Prevalence of asymptomatic carrier of bacterial, virale and/or parasitary
pathogens.
(2) Identification of subgroeps within the group of CVID patients:
determination of possible relationship with (B cel) fenotype en genotype (CVID
gerelateerde B cel mutaties) and the gastrointestinale pathology.
Study design
Cross sectionele analysis during a regular performed gastroscopy and
colonoscopy with extra biopsies of colon tissue.
Prospective follow study after 3 years
Study burden and risks
Colonoscopy and gastroscopy are part of the regular 3 year follow up of
patients with a primary antibodydeficiency.
The risks related to this researchproject are related to the extra colon
biopsies. The risk of perforation or bleeding is 1:5000 biopsies.
Heidelberglaan
3508 GA Utrecht
NL
Heidelberglaan
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Primary antibodydeficiency:
1. Common Variable Immunodeficiency Syndrome (CVID)
2. X-linked agammaglobulinemia (XLA)
3. IgG subclasse deficiency
4. abnormal vaccinationrespons
Exclusion criteria
incapable to sign informed consent
Age younger than 18 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25742.041.08 |