ID

31525

Beschreibung

Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study; ODM derived from: https://clinicaltrials.gov/show/NCT01464151 Sponsor: UMC Utrecht Collaborators: Merck Sharp & Dohme Corp. Ferring Pharmaceuticals Information provided by (Responsible Party): B. Oldenburg, UMC Utrecht

Link

https://clinicaltrials.gov/show/NCT01464151

Stichworte

Versionen (1)
  1. 31.08.18 31.08.18 -
Rechteinhaber

B. Oldenburg, MD, PhD, UMC Utrecht

Hochgeladen am

31. August 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Inflammatory Bowel Disease NCT01464151

Englisch

Eligibility Inflammatory Bowel Disease NCT01464151

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
Beschreibung

diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0009324
UMLS CUI [2]
C0341332
UMLS CUI [3]
C0010346
disease duration ≥ 8 years
Beschreibung

disease duration ≥ 8 years

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
inflammation of at least 30 % of colonic mucosa at some point between ibd diagnosis and inclusion
Beschreibung

Inflammatory bowel disease inflammation spread prior to inclusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0449283
age 18 - 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent
Beschreibung

Signed informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
high grade dysplasia or colorectal cancer before inclusion
Beschreibung

High grade dysplasia or colorectal cancer before inclusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0555952
UMLS CUI [1,2]
C0334048
UMLS CUI [2]
C0009402
subtotal or total colectomy before inclusion
Beschreibung

Subtotal or total colectomy before inclusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0192871
UMLS CUI [2,1]
C0149750
UMLS CUI [2,2]
C0728939
clotting disorder or use of anticoagulants that can not be temporarily discontinued
Beschreibung

Clotting disorder or use of anticoagulants that can not be temporarily discontinued

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C1830593
serious comorbidities which prevent performing a colonoscopy
Beschreibung

Serious comorbidities which prevent performing a colonoscopy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1301624
UMLS CUI [1,4]
C0009378
limited life expectancy
Beschreibung

limited life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
clinical or endoscopical disease activity (at the discretion of the treating physician)
Beschreibung

Clinical or endoscopical disease activity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0544450
UMLS CUI [1,2]
C1710470
UMLS CUI [1,3]
C0871010
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Ähnliche Modelle

Eligibility Inflammatory Bowel Disease NCT01464151

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
Item
diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
boolean
C0009324 (UMLS CUI [1])
C0341332 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
disease duration ≥ 8 years
Item
disease duration ≥ 8 years
boolean
C0872146 (UMLS CUI [1])
Inflammatory bowel disease inflammation spread prior to inclusion
Item
inflammation of at least 30 % of colonic mucosa at some point between ibd diagnosis and inclusion
boolean
C0449283 (UMLS CUI [1])
Age
Item
age 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Signed informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
High grade dysplasia or colorectal cancer before inclusion
Item
high grade dysplasia or colorectal cancer before inclusion
boolean
C0555952 (UMLS CUI [1,1])
C0334048 (UMLS CUI [1,2])
C0009402 (UMLS CUI [2])
Subtotal or total colectomy before inclusion
Item
subtotal or total colectomy before inclusion
boolean
C0192871 (UMLS CUI [1])
C0149750 (UMLS CUI [2,1])
C0728939 (UMLS CUI [2,2])
Clotting disorder or use of anticoagulants that can not be temporarily discontinued
Item
clotting disorder or use of anticoagulants that can not be temporarily discontinued
boolean
C0005779 (UMLS CUI [1])
C0003281 (UMLS CUI [2,1])
C1830593 (UMLS CUI [2,2])
Serious comorbidities which prevent performing a colonoscopy
Item
serious comorbidities which prevent performing a colonoscopy
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0009378 (UMLS CUI [1,4])
limited life expectancy
Item
limited life expectancy
boolean
C0023671 (UMLS CUI [1])
Clinical or endoscopical disease activity
Item
clinical or endoscopical disease activity (at the discretion of the treating physician)
boolean
C0544450 (UMLS CUI [1,1])
C1710470 (UMLS CUI [1,2])
C0871010 (UMLS CUI [1,3])
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