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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR2851 |
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Date of registration:
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13/04/2011 |
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Primary sponsor: |
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Public title:
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Expressie van CCL25 en CCR9 bij inflammatoire darmziekten en primaire scleroserende cholangitis.
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Scientific title:
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Expression of CCL25 and CCR9 in human colon in IBD/PSC patients. - PSColon |
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Date of first enrolment:
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1/5/2009 |
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Target sample size:
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80 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2851 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: None; Control: [default]; Group: Parallel; Type: 2 or more arms, non-randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C. IJ.
Ponsioen |
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Address:
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Dept. Gastroenterology and Hepatology
Academic Medical Center Amsterdam
PO Box 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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c.y.ponsioen@amc.uva.nl |
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Affiliation:
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Name:
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K.
Boonstra |
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Address:
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PO Box 22660, Dept. Gastroenterology and Hepatology
Room C2-231
Academic Medical Center Amsterdam
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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k.boonstra@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Newly diagnosed PSC patients screened for IBD, ≥18 yr old;
2. a. Newly diagnosed UC patients, ≥18 yr old;
2. b. Infectious enterocolitis patients (bacterial/viral/parasitic), ≥18 yr old;
3. PSC/UC surveillance patients, ≥18 yr old;
4. UC surveillance patients, ≥18 yr old;
5. Controls referred for CRC screening, ≥18 yr old.
Exclusion criteria: 1. Inability to give informed consent;
2. Bleeding diathesis.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Crohn's disease, Ulcerative Colitis, Inflammatory bowel disease, Primary sclerosing cholangitis
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Intervention(s)
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Ileal and colonic biopsies during colonoscopy.
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Primary Outcome(s)
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Expression of CCL25 in human colon.
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Secondary Outcome(s)
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1. Semiquantitative analyses of CCL25 and/or CCR9+ lymphocytes in double stained colonic biopsies between patients and controls;
2. Quantitative analyses of CCL25 mRNA in colon of patients and controls;
3. Quantitative analyses α4β7/CCR9+ T cells in peripheral blood.
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Secondary ID(s)
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MEC 09/059
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
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