The aim of this pilot study is to determine the diagnostic value of exhaled breath analysis by eNose technology for endometriosis patients: does it detect endometriosis?
ID
Source
Brief title
Condition
- Other condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Health condition
endometriose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome consist of exhaled breath profiles obtained by sampling
exhaled breath using eNose technology. These profiles form a characteristic
fingerprint of the Volatile Organic Compounds (VOC*s) present in exhaled
breath. The profiles of both endometriosis patients and healthy controls will
be analysed and compared to determine the sensitivity and specificity of the
eNose technology in diagnosing endometriosis.
Secondary outcome
The sensitivity and specificity of the eNose technology in differentiating
between early and advanced stages of endometriosis.
Background summary
Endometriosis is a prevalent gynaecological condition, in which inflammation
and oxidative stress cause pain and fibrotic lesions, which can lead to
infertility in some women. The current gold standard for diagnosing
endometriosis is laparoscopic visualization of the lesions with histological
confirmation. Research has been unable to identify an accurate non-invasive
marker. Since the invasiveness of the current diagnostic method contributes to
the diagnostic delay, which results in more severe fibrotic lesions and
irreversible damage like infertility, there is an urgent need for a
non-invasive diagnostic biomarker. The inflammation and oxidative stress that
is associated with endometriosis, suggests patients with endometriosis are
likely to have an altered metabolic profile, which can be detected with
electronic-nose (eNose) technology.
Study objective
The aim of this pilot study is to determine the diagnostic value of exhaled
breath analysis by eNose technology for endometriosis patients: does it detect
endometriosis?
Study design
This study is a one-center cross-sectional case-control study.
Study burden and risks
There are no risks associated with participating in this study and the burden
is expected to be low. Subjects will only be required to perform a breath test
similar to spirometry during a single visit to the hospital and will not be
subjected to any invasive testing. The data collected in this study will not
directly benefit participants, but hopefully will result in a low burden,
non-invasive, diagnostic test for endometriosis in patients with clinical
suspicion of endometriosis.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Cases:
- Aged between 18-40 years.
- (1) diagnosed with endometriosis by laparoscopy OR (2) diagnosed with deep
invasive endometriosis (DIE) by MRI after positive gynecological examination
and subsequent ultrasound.
Controls:
- Aged between 18-40 years.
- Conformed absence of endometriosis by laparoscopy (e.g. sterilization,
extra-uterine pregnancy, diagnostic in case of infertility) or laparotomy (e.g.
cesarean section).
Exclusion criteria
- Underage women (<18 years)
- Postmenopausal women or women >40 years
- Pregnancy or currently breastfeeding
- Diagnosed adenomyosis without endometriosis
- Alcohol consumption <12 hours before testing
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL74072.058.20 |