In this pilot study will focus on the question whether it is possible to detect and distinguish specific immune cells which are previously found in endometriotic tissue, in , macroscopically non-affected peritoneum, peritoneal fluid, peripheral…
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be the presence of CD4+ and CD8+ T-lymphocytes
in the different tissue samples.
Secondary outcome
Furthermore, we will assess patient factors and characteristics of the
endometriotic lesion on the T-cell infiltration.
Background summary
Endometriosis has a prevalence of around 10% in females of the reproductive
age. A part of the women affected with the disease can have severe symptoms,
most of the times varying with the menstrual cycle. The pathogenesis has been
researched, creating certain theories, of which the most popular being the
regurgitation theory. However, these theories do not explain how endometriosis
dodges the immune system and prevails. Research has been done concerning the
immune system in such as macrophages, cytokines, natural killer cells and
dendritic cells.
Study objective
In this pilot study will focus on the question whether it is possible to detect
and distinguish specific immune cells which are previously found in
endometriotic tissue, in , macroscopically non-affected peritoneum, peritoneal
fluid, peripheral blood and uterine endometrial samples, which are of patients
with endometriosis as well.
Study design
The study design is a cross-sectional, within-patient comparative pilot study,
The tissue samples will be collected during surgery. These tissue samples will
be stored and analyzed.
Study burden and risks
There will be no direct benefit for the participating women, other than the
perspective of the feeling to contribute to extending the knowledge on
endometriosis. The biopsy of visually unaffected peritoneum will extend the
operation time with 5-10 minutes (related to operations of 120-480 minutes),
with minimum risk when collected with sufficient distance to essential organs
(<1%).
The sampling of endometrial tissue from the uterus, via the vaginal route can
result in infection, bleeding, scarring and damage to the uterus, with a low
risk (<1%) . Peritoneal fluid will be collected during the operation with a
minimum of risk (<0,1%) and a minimal extension of operation time.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Patients between 18-56 years with confirmed endometriosis planned for
surgical excision of endometriosis
- Patients being able to read and understand the patient information form
- Signed informed consent
Exclusion criteria
- History of an autoimmune disease, specifically hepatitis A virus (HAV),
hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency
virus (HIV), or any other systemic intercurrent disease or condition that might
affect the immunocompetence of the patient
- Treatment with systemic highly immunosuppressive therapy (e.g. transplant
recipients)
- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
p.o. >7.5 mg/day)
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 | NL73656.042.20 |