To determine which DC populations are present in esophageal tissue of patients with reflux esophagitis and BE. Relate the findings regarding DC populations to other pre-malignant gastrointestinal disorders (IBD).
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a significant difference in the number and type of
DCs in the esophagus of patients with chronic gastro esophageal reflux disease
and BE.
Secondary outcome
- To determine DC populations in blood
- To relate the above-mentioned findings of DC to other pre-malignant
gastrointestinal disorders, i.e., Crohn*s disease and ulcerative colitis.
Background summary
It is known that chronic inflammation predisposes to development of cancer. In
Barrett*s esophagus (BE), a pre-malignant condition of the esophagus, normal
squamous epithelium is replaced by intestinal columnar epithelial cells. Its
formation coincides with chronic inflammation. BE predisposes to development of
adenocarcinoma in the esophagus. Dendritic cells (DCs) play a crucial role in
the induction of an immune response, and maintenance of chronic inflammation.
DCs are the only antigen presenting cells capable of activating naïve T
lymphocytes. Here, we will study which types of DCs are present in inflammatory
pre-malignant disease in the esophagus. By identifying the changes in DC
activation and its relation to squamous versus columnar epithelial cells, we
will be able to pinpoint new therapeutic targets for Barrett*s esophagus and
thereby prevent chronic inflammation and the progression to adenocarcinoma.
Study objective
To determine which DC populations are present in esophageal tissue of patients
with reflux esophagitis and BE. Relate the findings regarding DC populations to
other pre-malignant gastrointestinal disorders (IBD).
Study design
This is a cohort study, in which extra biopsies will be taken during diagnostic
endoscopy at the outpatient clinic in the UMC Utrecht. Patients scheduled for
endoscopy of the esophagus or colon for the indications 1) Reflux esophagitis
2) Barrett*s esophagus 3) Ulcerative colitis, or 4) Crohn*s disease will be
asked to participate in this study. From each group 20 patients are included in
this study. Inclusion of patients in this study protocol will therefore not
lead to extra upper or lower gastrointestinal endoscopy. In addition to
biopsies we will ask the patient for donation of three tubes (21 ml) of blood
and we will as them to fill out two short questionnaires.
Study burden and risks
The patients will undergo endoscopy for diagnostic purposes; during this
procedure six to eight extra biopsies will be taken, meaning that patients do
not undergo an extra endoscopy. Participation does not involve an increased
risk during endoscopy; the procedure will take about two minutes longer. We
also ask the patients to fill out two questionnaires and we will ask them to
donate three tubes (21 ml) of blood.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- >= 18 years old
- written informed consent
- upper or lower gastrointestinal tract endoscopy for diagnosis or follow-up of pre-malignant disorder of the gastrointestinal tract
Exclusion criteria
- pregnancy
- esophagectomy, gastrectomy
- total proctocolectomy
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 | NL18901.041.07 |