ID

20182

Descrição

Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC); ODM derived from: https://clinicaltrials.gov/show/NCT00483080

Link

https://clinicaltrials.gov/show/NCT00483080

Palavras-chave

Versões (1)
  1. 10/02/2017 10/02/2017 -
Transferido a

10 de fevereiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Cancer (CRC) NCT00483080

Inglês

Eligibility Colorectal Cancer (CRC) NCT00483080

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients >18 years affected by advanced or metastatic colorectal cancer (crc), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy
Descrição

Age | Colorectal Carcinoma Advanced phase | Colorectal cancer metastatic | fluoropyrimidine | oxaliplatin | irinotecan | Therapeutic procedure Quantity | Chemotherapy, Adjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0009402
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0948380
UMLS CUI [4]
C0596581
UMLS CUI [5]
C0069717
UMLS CUI [6]
C0123931
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0085533
ecog performance status 0 - 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients in progression disease at study entry, ct documented
Descrição

Disease Progression X-Ray Computed Tomography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0040405
adequate baseline bone marrow, hepatic and renal function, defined as follows:
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
neutrophils > 1.5 x 10^9/l and platelets > 100 x 10^9/l
Descrição

Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
bilirubin < 1.5 x uln
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
ast and/or alt < 2.5 x uln in absence of liver metastases
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
ast and/or alt < 5 x uln in presence of liver metastases
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Present

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0150312
serum creatinine < 1.5 x uln
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin")
Descrição

Fluid overload Patient Risk Absent | Hemodilution Patient Risk Absent | Increased cardiac stroke volume | Increase in blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0546817
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0019009
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C0332197
UMLS CUI [3]
C0520872
UMLS CUI [4]
C0497247
normal cardiac function and absence of uncontrolled hypertension
Descrição

Cardiac function | Uncontrolled hypertension Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332197
patients must give written informed consent to participate in the study
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than three lines of chemotherapy (except biological agents)
Descrição

Chemotherapy Quantity | Biological Factors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0005515
concurrent anticancer therapy
Descrição

cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
patients may not receive any other investigational agents while on study
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
clinical signs of cns involvement
Descrição

Central Nervous System Involvement Sign or Symptom

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C3540840
patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
Descrição

Systemic disease Inconsistent Study Protocol | Systemic disease Uncontrolled Inconsistent Study Protocol | Communicable Diseases Inconsistent Study Protocol | Communicable Diseases Uncontrolled Inconsistent Study Protocol | Illness Serious Inconsistent Study Protocol | Medical condition Inconsistent Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0442809
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0442809
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0442809
UMLS CUI [4,4]
C2348563
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0442809
UMLS CUI [5,4]
C2348563
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0442809
UMLS CUI [6,3]
C2348563
known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
Descrição

Hypersensitivity Human Albumin | Allergic Reaction Human Albumin | Hypersensitivity Human Albumin Excipient | Allergic Reaction Human Albumin Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304925
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0304925
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0304925
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0304925
UMLS CUI [4,3]
C0015237
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Descrição

Condition Psychologic Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205486
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
pregnancy or lactation. patients - both males and females - with reproductive potential (i.e.menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Descrição

Pregnancy | Breast Feeding | Reproductive potential Contraceptive methods | Menopause | Sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0025320
UMLS CUI [5]
C0038288
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430061
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
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Similar models

Eligibility Colorectal Cancer (CRC) NCT00483080

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Colorectal Carcinoma Advanced phase | Colorectal cancer metastatic | fluoropyrimidine | oxaliplatin | irinotecan | Therapeutic procedure Quantity | Chemotherapy, Adjuvant
Item
patients >18 years affected by advanced or metastatic colorectal cancer (crc), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy
boolean
C0001779 (UMLS CUI [1])
C0009402 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0948380 (UMLS CUI [3])
C0596581 (UMLS CUI [4])
C0069717 (UMLS CUI [5])
C0123931 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0085533 (UMLS CUI [8])
ECOG performance status
Item
ecog performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Disease Progression X-Ray Computed Tomography
Item
patients in progression disease at study entry, ct documented
boolean
C0242656 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
adequate baseline bone marrow, hepatic and renal function, defined as follows:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophils > 1.5 x 10^9/l and platelets > 100 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent
Item
ast and/or alt < 2.5 x uln in absence of liver metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Present
Item
ast and/or alt < 5 x uln in presence of liver metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine < 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Fluid overload Patient Risk Absent | Hemodilution Patient Risk Absent | Increased cardiac stroke volume | Increase in blood pressure
Item
absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin")
boolean
C0546817 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0019009 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0520872 (UMLS CUI [3])
C0497247 (UMLS CUI [4])
Cardiac function | Uncontrolled hypertension Absent
Item
normal cardiac function and absence of uncontrolled hypertension
boolean
C0232164 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
patients must give written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Quantity | Biological Factors
Item
more than three lines of chemotherapy (except biological agents)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2])
cancer treatment
Item
concurrent anticancer therapy
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not receive any other investigational agents while on study
boolean
C0013230 (UMLS CUI [1])
Central Nervous System Involvement Sign or Symptom
Item
clinical signs of cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Systemic disease Inconsistent Study Protocol | Systemic disease Uncontrolled Inconsistent Study Protocol | Communicable Diseases Inconsistent Study Protocol | Communicable Diseases Uncontrolled Inconsistent Study Protocol | Illness Serious Inconsistent Study Protocol | Medical condition Inconsistent Study Protocol
Item
patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
boolean
C0442893 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0442809 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0442809 (UMLS CUI [4,3])
C2348563 (UMLS CUI [4,4])
C0221423 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0442809 (UMLS CUI [5,3])
C2348563 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0442809 (UMLS CUI [6,2])
C2348563 (UMLS CUI [6,3])
Hypersensitivity Human Albumin | Allergic Reaction Human Albumin | Hypersensitivity Human Albumin Excipient | Allergic Reaction Human Albumin Excipient
Item
known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0304925 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0304925 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1527304 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Condition Psychologic Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
boolean
C0348080 (UMLS CUI [1,1])
C0205486 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Reproductive potential Contraceptive methods | Menopause | Sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
pregnancy or lactation. patients - both males and females - with reproductive potential (i.e.menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0025320 (UMLS CUI [4])
C0038288 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
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