To identify predictive parameters for typhlitis in AML patients treated with intensive chemotherapy.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Defining the severity of epithelial dysfunction measured with mucositis
score; the stool volume; the calprotectin level in the stool the urinary Cr
EDTA excretion and serum IL-8 and CRP levels.
- Typhlitis based on clinical symptomatology and CT-scanning abdomen.
- DNA isolation from normal peripheral blood cells for determining polymorphism
of metabolism genes.
Secondary outcome
Not applicable.
Background summary
10-20% of the patients with acute myeloid leukaemia (AML) develop typhlitis
following intensive chemotherapy. This might be related to cytotoxic effects of
chemotherapy to epithelial and endothelial cells. So far no predictive
parameters have been identified that can recognize this subgroup of patients.
Study objective
To identify predictive parameters for typhlitis in AML patients treated with
intensive chemotherapy.
Study design
Pilot study. AML patients that have been treated with intensive chemotherapy
will be followed during 14-days following chemotherapy regarding parameters
that reflect epithelial damage.
Study burden and risks
Intervention
- Blood and stool samples will be collected
- Echography of abdomen at day 10-12
- Mucositis score will be determined
- DNA isolation from normal peripheral blood
Procedure
- Sampling blood and stool
- Echography
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
- age 18-70 years
- patients with AML treated with intensive chemotherapy
Exclusion criteria
Ineligible to perform the proposed tests.
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 | NL23201.042.08 |