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Typhlitis study.


- candidate number5699
- NTR NumberNTR1800
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mei-2009
- Secondary IDs2008/113 MEC UMCG
- Public TitleTyphlitis study.
- Scientific TitleIdentification of predictive parameters for typhlitis in AML patients treated with intensive chemotherapy.
- ACRONYMTyphlitis in AML
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. Age 18-70 years;
2. Diagnosed with AML and treated with intensive chemotherapy.
- Exclusion criteriaIneligible to perform the tests.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2008
- planned closingdate1-jun-2011
- Target number of participants45
- Interventions1. Blood and stool samples will be collected;
2. CT-scan of abdomen at day 10-12;
3. Mucositis score will be determined;
4. DNA isolation from normal peripheral blood.
- Primary outcome1. 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;
2. Typhlitis based on clinical symptomatology and CT-scanning abdomen.
- Secondary outcomeBefore and after treatment with chemo different parameters will be examined.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. E. Vellenga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. E. Vellenga
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryRationale:
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.

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 population:
1. Patient age 18-70 years;
2. Treated for AML with intensive chemotherapy.

Intervention:
1. Blood and stool samples will be collected;
2. CT-scan of abdomen at day 10-12;
3. Mucositis score will be determined;
4. DNA isolation from normal peripheral blood.

Main study parameters/endpoints:
1. 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;
2. Typhlitis based on clinical symptomatology and CT-scanning abdomen.

Procedure:
1. Sampling blood and stool;
2. CT-scan.

Investigations:
1. Mucositis score; stool volume;
2. Serum IL-8 and CRP levels;
3. Urinary excretion of;
4. CT-scan abdomen;
5. DNA isolation from normal peripheral blood.

Country of recruitment:
The Netherlands.
- Main changes (audit trail)
- RECORD6-mei-2009 - 30-sep-2009


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