ID

16427

Beschrijving

Phase II Study for Solid Metastatic Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT02474186

Link

https://clinicaltrials.gov/show/NCT02474186

Trefwoorden

Versies (1)
  1. 16-07-16 16-07-16 -
Geüploaded op

16 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02474186

Engels

Eligibility Breast Cancer NCT02474186

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed breast cancer or other cancer which is persistent and metastatic or recurrent and metastatic.
Beschrijving

Breast Carcinoma | Metastatic Neoplasm persistent | Metastatic Neoplasm Recurrent

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0205322
UMLS CUI [3,1]
C2939420
UMLS CUI [3,2]
C2945760
patients with a history of treatment for other prior malignancy will be eligible, provided they remain disease-free > 2 years after initial treatment, or were treated for non-melanoma skin cancer, or in situ cervical cancer.
Beschrijving

Therapeutic procedure Malignant Neoplasms | Therapeutic procedure Initial | Disease Free of | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205265
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
UMLS CUI [4,1]
C0699893
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0851140
UMLS CUI [5,2]
C1522326
patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter.
Beschrijving

Anatomical sites Metastatic Measurable | Diameter size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005898
UMLS CUI [1,2]
C0036525
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0456389
age >18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status <2 (karnofsky >50%).
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had immunotherapy within 4 weeks prior to entering the study.
Beschrijving

Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021083
patients who have had prior allergic reaction to gm-csf
Beschrijving

Allergic Reaction GM-CSF

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0079460
patients on steroid therapy or other immunosuppressive therapy.
Beschrijving

Steroid therapy | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0021079
patients undergoing therapy with other investigational agents.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion.
Beschrijving

Metastatic malignant neoplasm to brain | Lesion of brain | Target Lesion Identification | Non-Target Lesion Identification

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0221505
UMLS CUI [3]
C2986546
UMLS CUI [4]
C2986547
uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina pectoris, or unstable cardiac arrhythmia requiring assessment for clinical intervention.
Beschrijving

Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Myocardial Infarction | Angina, Unstable | Cardiac Arrhythmia Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0443343
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Similar models

Eligibility Breast Cancer NCT02474186

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Metastatic Neoplasm persistent | Metastatic Neoplasm Recurrent
Item
patients with histologically confirmed breast cancer or other cancer which is persistent and metastatic or recurrent and metastatic.
boolean
C0678222 (UMLS CUI [1])
C2939420 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C2939420 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
Therapeutic procedure Malignant Neoplasms | Therapeutic procedure Initial | Disease Free of | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated
Item
patients with a history of treatment for other prior malignancy will be eligible, provided they remain disease-free > 2 years after initial treatment, or were treated for non-melanoma skin cancer, or in situ cervical cancer.
boolean
C0087111 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0699893 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
Anatomical sites Metastatic Measurable | Diameter size
Item
patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter.
boolean
C0005898 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C1301886 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Age
Item
age >18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status <2 (karnofsky >50%).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunotherapy
Item
patients who have had immunotherapy within 4 weeks prior to entering the study.
boolean
C0021083 (UMLS CUI [1])
Allergic Reaction GM-CSF
Item
patients who have had prior allergic reaction to gm-csf
boolean
C1527304 (UMLS CUI [1,1])
C0079460 (UMLS CUI [1,2])
Steroid therapy | Therapeutic immunosuppression
Item
patients on steroid therapy or other immunosuppressive therapy.
boolean
C0149783 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Investigational New Drugs
Item
patients undergoing therapy with other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Lesion of brain | Target Lesion Identification | Non-Target Lesion Identification
Item
patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion.
boolean
C0220650 (UMLS CUI [1])
C0221505 (UMLS CUI [2])
C2986546 (UMLS CUI [3])
C2986547 (UMLS CUI [4])
Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Myocardial Infarction | Angina, Unstable | Cardiac Arrhythmia Unstable
Item
uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina pectoris, or unstable cardiac arrhythmia requiring assessment for clinical intervention.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
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