ID

42609

Description

Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00489697

Lien

https://clinicaltrials.gov/show/NCT00489697

Mots-clés

Versions (2)
  1. 09/08/2017 09/08/2017 -
  2. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00489697

Anglais

Eligibility Metastatic Colorectal Cancer NCT00489697

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed colorectal tumor
Description

Colorectal Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0009402
first line treatment by a bevacizumab based chemotherapy
Description

First line treatment Chemotherapy | bevacizumab

Type de données

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0796392
target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and ct or mri
Description

Target Secondary malignant neoplasm of liver Size | Ultrasonography | X-Ray Computed Tomography | Magnetic Resonance Imaging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0494165
UMLS CUI [1,3]
C0456389
UMLS CUI [2]
C0041618
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0024485
life expectancy > 2 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
oms status =< 2
Description

WHO performance status scale

Type de données

boolean

Alias
UMLS CUI [1]
C1298650
major surgery, open biopsy, or significant traumatic injury within 28 days prior to day 0
Description

Major surgery | Incisional biopsy | Traumatic injury

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
informed consent signed
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no target hepatic lesion detected by conventional ultrasonography
Description

Target Lesion of liver Absent | Ultrasonography

Type de données

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0577053
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0041618
prior bevacizumab treatment
Description

Bevacizumab Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0796392
UMLS CUI [1,2]
C1514463
prior chemotherapy treatment for advanced disease
Description

Chemotherapy Advanced disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0679246
clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
Description

Heart Diseases | Myocardial Infarction | Cerebrovascular accident | Angina, Unstable | Congestive heart failure Poorly controlled New York Heart Association Classification | Endocarditis | Prosthetic valve | Medical contraindication Sulfur Hexafluoride

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C3853134
UMLS CUI [5,3]
C1275491
UMLS CUI [6]
C0014118
UMLS CUI [7]
C0336548
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0038779
blood pressure >= 180/110 mmhg
Description

Blood pressure measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0005824
daily and chronic treatment by aspirin or ains
Description

Aspirin Daily chronic | Non-Steroidal Anti-Inflammatory Agents Daily chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0205191
anticipation of need for major surgical procedure within 7 days prior day 0
Description

Major surgery Need Anticipated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0027552
UMLS CUI [1,3]
C3840775
urine protein > 1g/24 hours
Description

Urine protein test

Type de données

boolean

Alias
UMLS CUI [1]
C0262923
any contraindication in enhancing bevacizumab treatment
Description

Medical contraindication Bevacizumab

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0796392
serious, uncontrolled, concurrent infection(s) or illness(es)
Description

Communicable Diseases Uncontrolled Serious | Illness Uncontrolled Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0205404
pregnant and lactating woman
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00489697

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma
Item
histologically confirmed colorectal tumor
boolean
C0009402 (UMLS CUI [1])
First line treatment Chemotherapy | bevacizumab
Item
first line treatment by a bevacizumab based chemotherapy
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0796392 (UMLS CUI [2])
Target Secondary malignant neoplasm of liver Size | Ultrasonography | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and ct or mri
boolean
C1521840 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
Life Expectancy
Item
life expectancy > 2 months
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
oms status =< 2
boolean
C1298650 (UMLS CUI [1])
Major surgery | Incisional biopsy | Traumatic injury
Item
major surgery, open biopsy, or significant traumatic injury within 28 days prior to day 0
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Target Lesion of liver Absent | Ultrasonography
Item
no target hepatic lesion detected by conventional ultrasonography
boolean
C1521840 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
Bevacizumab Prior Therapy
Item
prior bevacizumab treatment
boolean
C0796392 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Chemotherapy Advanced disease
Item
prior chemotherapy treatment for advanced disease
boolean
C0392920 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
Heart Diseases | Myocardial Infarction | Cerebrovascular accident | Angina, Unstable | Congestive heart failure Poorly controlled New York Heart Association Classification | Endocarditis | Prosthetic valve | Medical contraindication Sulfur Hexafluoride
Item
clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
C0014118 (UMLS CUI [6])
C0336548 (UMLS CUI [7])
C1301624 (UMLS CUI [8,1])
C0038779 (UMLS CUI [8,2])
Blood pressure measurement
Item
blood pressure >= 180/110 mmhg
boolean
C0005824 (UMLS CUI [1])
Aspirin Daily chronic | Non-Steroidal Anti-Inflammatory Agents Daily chronic
Item
daily and chronic treatment by aspirin or ains
boolean
C0004057 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Major surgery Need Anticipated
Item
anticipation of need for major surgical procedure within 7 days prior day 0
boolean
C0679637 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
Urine protein test
Item
urine protein > 1g/24 hours
boolean
C0262923 (UMLS CUI [1])
Medical contraindication Bevacizumab
Item
any contraindication in enhancing bevacizumab treatment
boolean
C1301624 (UMLS CUI [1,1])
C0796392 (UMLS CUI [1,2])
Communicable Diseases Uncontrolled Serious | Illness Uncontrolled Serious
Item
serious, uncontrolled, concurrent infection(s) or illness(es)
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant and lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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