ID

20192

Beschreibung

Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00327093

Link

https://clinicaltrials.gov/show/NCT00327093

Stichworte

Versionen (1)
  1. 11.02.17 11.02.17 -
Hochgeladen am

11. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00327093

Englisch

Eligibility Colorectal Cancer NCT00327093

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients >= 18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with colon or rectal carcinoma histologically proven
Beschreibung

Colon Carcinoma | Rectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0699790
UMLS CUI [2]
C0007113
patients with metastases (synchronous or metachronous)
Beschreibung

Metastases Synchronous | Metastases Timepoint Different

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0439580
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2348792
UMLS CUI [2,3]
C1705242
patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
Beschreibung

Disease Extrahepatic Associated | Primary tumor Asymptomatic | Neoplasm Metastasis Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C0332281
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1517058
performance status (world health organization [who]) = 0, 1, or 2
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy >= 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patients with normal haematological, kidney, and liver parameters (pnn > 1.5 x 10^9/l, platelets > 100 10^9/l, total bilirubin <= 1.25 x upper limit of normal (uln), asat/alat <= 5 x uln, creatinaemia <= 135 µmol/l (1.5 mg/dl)
Beschreibung

Hematologic function | Renal function | Liver function | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201976
no cardiac or coronary insufficiency untreated
Beschreibung

Heart failure Untreated | Coronary artery insufficiency Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0542052
UMLS CUI [2,2]
C0332155
at least 4 weeks between surgery and study beginning
Beschreibung

Operative Surgical Procedure Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
patients can have a biopsy of the hepatic lesion identified by ultrasound.
Beschreibung

Lesion of liver Biopsy | Identification Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0205396
UMLS CUI [2,2]
C0041618
informed consent signed.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with symptomatic tumors (colon or rectal)
Beschreibung

Colon Carcinoma Symptomatic | Rectal Carcinoma Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0699790
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0007113
UMLS CUI [2,2]
C0231220
patients with others tumors not cured
Beschreibung

Malignant Neoplasms Cure Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0679252
UMLS CUI [1,3]
C0332268
patients who cannot be treated by 5-fluorouracil (5-fu) and/or irinotecan because of special medical conditions or other serious disease.
Beschreibung

Fluorouracil | Irinotecan | Untreated Due to Medical condition Special | Untreated Due to Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0016360
UMLS CUI [2]
C0123931
UMLS CUI [3,1]
C0332155
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C3843040
UMLS CUI [3,4]
C0205555
UMLS CUI [4,1]
C0332155
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0012634
UMLS CUI [4,4]
C0205404
patients who participated in another clinical trial since less than 30 days
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
pregnancy or breast-feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who cannot be treated because of active infection or other serious disease.
Beschreibung

Untreated Due to Communicable Disease | Untreated Due to Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0332155
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0205404
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00327093

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Colon Carcinoma | Rectal Carcinoma
Item
patients with colon or rectal carcinoma histologically proven
boolean
C0699790 (UMLS CUI [1])
C0007113 (UMLS CUI [2])
Metastases Synchronous | Metastases Timepoint Different
Item
patients with metastases (synchronous or metachronous)
boolean
C0027627 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2348792 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
Disease Extrahepatic Associated | Primary tumor Asymptomatic | Neoplasm Metastasis Extrahepatic
Item
patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
WHO performance status scale
Item
performance status (world health organization [who]) = 0, 1, or 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >= 3 months
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
patients with normal haematological, kidney, and liver parameters (pnn > 1.5 x 10^9/l, platelets > 100 10^9/l, total bilirubin <= 1.25 x upper limit of normal (uln), asat/alat <= 5 x uln, creatinaemia <= 135 µmol/l (1.5 mg/dl)
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
Heart failure Untreated | Coronary artery insufficiency Untreated
Item
no cardiac or coronary insufficiency untreated
boolean
C0018801 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0542052 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Operative Surgical Procedure Previous
Item
at least 4 weeks between surgery and study beginning
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lesion of liver Biopsy | Identification Ultrasonography
Item
patients can have a biopsy of the hepatic lesion identified by ultrasound.
boolean
C0577053 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205396 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Informed Consent
Item
informed consent signed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Colon Carcinoma Symptomatic | Rectal Carcinoma Symptomatic
Item
patients with symptomatic tumors (colon or rectal)
boolean
C0699790 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007113 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Malignant Neoplasms Cure Lacking
Item
patients with others tumors not cured
boolean
C0006826 (UMLS CUI [1,1])
C0679252 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Fluorouracil | Irinotecan | Untreated Due to Medical condition Special | Untreated Due to Disease Serious
Item
patients who cannot be treated by 5-fluorouracil (5-fu) and/or irinotecan because of special medical conditions or other serious disease.
boolean
C0016360 (UMLS CUI [1])
C0123931 (UMLS CUI [2])
C0332155 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C3843040 (UMLS CUI [3,3])
C0205555 (UMLS CUI [3,4])
C0332155 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C0205404 (UMLS CUI [4,4])
Study Subject Participation Status
Item
patients who participated in another clinical trial since less than 30 days
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Untreated Due to Communicable Disease | Untreated Due to Disease Serious
Item
patients who cannot be treated because of active infection or other serious disease.
boolean
C0332155 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0332155 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0205404 (UMLS CUI [2,4])
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