ID

28136

Beschreibung

Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00851045

Link

https://clinicaltrials.gov/show/NCT00851045

Stichworte

Versionen (1)
  1. 20.12.17 20.12.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Dezember 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Cancer (CRC) NCT00851045

Englisch

Eligibility Colorectal Cancer (CRC) NCT00851045

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status (ps) ≤1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed, unresectable metastatic colorectal cancer
Beschreibung

Colorectal cancer metastatic unresectable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C1519810
measurable disease by recist guidelines
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
Beschreibung

Disease Progression | Status post First line treatment | fluoropyrimidine | oxaliplatin | bevacizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [3]
C0596581
UMLS CUI [4]
C0069717
UMLS CUI [5]
C0796392
available paraffin embedded tumor tissue
Beschreibung

Tumor tissue sample Paraffin Embedding Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0085185
UMLS CUI [1,3]
C0470187
willing to give a whole blood sample for the study of proteins and genetic polymorphisms
Beschreibung

Whole blood sample Provide Willing | Study Proteins | Study Genetic Polymorphism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0444256
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C0033684
UMLS CUI [3,1]
C2603343
UMLS CUI [3,2]
C0032529
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 28 days elapsed since major surgery at time of randomization
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
known cns metastases
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
Beschreibung

Bleeding Risk Excessive | Anticoagulation Therapy Except Aspirin Low Dose | Thrombotic stroke | Embolic stroke

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3251812
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2608320
UMLS CUI [3]
C0242129
UMLS CUI [4]
C0262469
uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
clinically significant cardiovascular disease
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
Beschreibung

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Datentyp

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
Beschreibung

Non-healing wound Serious | Peptic Ulcer | Bone Fracture Non-healing | Secondary malignant neoplasm of skin bleeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0030920
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0205301
UMLS CUI [4,1]
C0153687
UMLS CUI [4,2]
C0019080
known hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
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Ähnliche Modelle

Eligibility Colorectal Cancer (CRC) NCT00851045

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status (ps) ≤1
boolean
C1520224 (UMLS CUI [1])
Colorectal cancer metastatic unresectable
Item
histologically or cytologically confirmed, unresectable metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease by recist guidelines
boolean
C1513041 (UMLS CUI [1])
Disease Progression | Status post First line treatment | fluoropyrimidine | oxaliplatin | bevacizumab
Item
evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0596581 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
Tumor tissue sample Paraffin Embedding Available
Item
available paraffin embedded tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C0085185 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Whole blood sample Provide Willing | Study Proteins | Study Genetic Polymorphism
Item
willing to give a whole blood sample for the study of proteins and genetic polymorphisms
boolean
C0444256 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C2603343 (UMLS CUI [2,1])
C0033684 (UMLS CUI [2,2])
C2603343 (UMLS CUI [3,1])
C0032529 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Major surgery
Item
less than 28 days elapsed since major surgery at time of randomization
boolean
C0679637 (UMLS CUI [1])
CNS metastases
Item
known cns metastases
boolean
C0686377 (UMLS CUI [1])
Bleeding Risk Excessive | Anticoagulation Therapy Except Aspirin Low Dose | Thrombotic stroke | Embolic stroke
Item
excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
boolean
C3251812 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2608320 (UMLS CUI [2,3])
C0242129 (UMLS CUI [3])
C0262469 (UMLS CUI [4])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Non-healing wound Serious | Peptic Ulcer | Bone Fracture Non-healing | Secondary malignant neoplasm of skin bleeding
Item
serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3,1])
C0205301 (UMLS CUI [3,2])
C0153687 (UMLS CUI [4,1])
C0019080 (UMLS CUI [4,2])
HIV Seropositivity
Item
known hiv positive
boolean
C0019699 (UMLS CUI [1])
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