The primary objective of this study is to assess whether *omics technologies are sensitive and specific enough to be used as a chemical risk assessment tool for humans. More specifically the study will demonstrate if there are different and / or…
ID
Source
Brief title
Condition
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are changes in gene expression profile and
metabolomic profile measured after and caused by APAP exposure.
Secondary outcome
n.a.
Background summary
Chemical compounds have to be toxicologically evaluated before the are allowed
on the market. Studying *omics effects of low to high paracetamol (APAP) dose
exposure in humans enables the validation of *omics technologies as a chemical
risk assessment tool for humans. Validation of these techniques might in future
enable us to reduce or maybe even replace the need of animal testing in
chemical risk assessment.
Study objective
The primary objective of this study is to assess whether *omics technologies
are sensitive and specific enough to be used as a chemical risk assessment tool
for humans.
More specifically the study will demonstrate if there are different and / or
similar toxicological effects caused by a low, normal or high dose of APAP, and
whether these effects can be seen in human peripheral lymphocytes and / or
urine.
Study design
This study includes 5 study groups: patients with liver resection, patients
with pancreas resection and 3 groups of healthy volunteers. Liver and pancreas
resection patients receive a daily dose of 4*1 gram APAP over 24 hours, which
is a commonly used analgesic therapy and should therefore not be regarded as an
intervention. Group 3-5, consisting of healthy volunteers receive once a dose
of 0.5, or 2 or 4 grams APAP (4 portions over 24 hours). Blood samples will be
collected before the intake of APAP, and 1 hour after the first, second and
fourth administration of APAP. Urine samples will be collected before and after
the intake of APAP.
Intervention
An intervention is only applicable to study group 3-5, healthy volunteers,
receiving a low dose of 2 gram APAP (4*0.5 gram APAP over 24 hours).
In study group 1 and 2, the administration of 4 grams APAP is not considered an
intervention since it is part of the normal analgesic treatment after resection
surgery.
Study burden and risks
The risks and burden associated with participation include:
- blood sampling (15 samples for the patients, 4 samples for the volunteers)
- urine collection (1 spot urine before, 24 h during APAP use)
- intake of APAP for the volunteers (not being part of a personal therapy)
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
For liver / pancreas resection patients:
•All patients undergoing a non laparoscopic liver or pancreas resection.
•Age above 18 years
For healthy volunteers:
•Age match to liver / colon resection group
Exclusion criteria
•Alcohol abuse up to 6 months before participation in this research.
•Aberrations or insufficiency of kidney, liver, gut, heart or longs apart from the disease to be treated.
•Presence of persistent inflammation in the gut or liver.
•Use of drug known to affect the liver metabolism.
•Endocrine or metabolic aberrations.
•Anaemia or infection.
•HIV infection or hepatitis.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-010279-25-NL |
| CCMO | NL26884.068.09 |
| Other | trialregister.nl |