ID

31199

Beskrivning

Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01130766

Länk

https://clinicaltrials.gov/show/NCT01130766

Nyckelord

Versioner (1)
  1. 2018-07-27 2018-07-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01130766

Engelsk

Eligibility Non-small Cell Lung Cancer NCT01130766

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
Beskrivning

Non-Small Cell Lung Carcinoma | Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0220650
one to 4 intraparenchymal brain metastases by contrast-enhanced mri, meeting the following criteria:
Beskrivning

Metastatic malignant neoplasm to brain Parenchymal Quantity MRI with contrast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C4277702
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0202671
1. well circumscribed tumor(s) with brain edema grade 0-1
Beskrivning

Tumor Circumscribed Well | Brain Edema CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1282914
UMLS CUI [1,3]
C0205170
UMLS CUI [2,1]
C1527311
UMLS CUI [2,2]
C1516728
2. maximum diameter ≤ 3.0 cm
Beskrivning

Diameter Maximum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C0806909
no prior complete resection of all known brain metastases or rt ④ no leptomeningeal metastases by mri or cerebrospinal fluid evaluation
Beskrivning

Metastatic malignant neoplasm to brain Complete excision Absent | Therapeutic radiology procedure | Metastatic Malignant Neoplasm to the Leptomeninges Absent MRI | Cerebrospinal Fluid Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0015250
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1704231
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0007806
UMLS CUI [4,2]
C1261322
patients without any symptoms or signs from brain metastases (rtog neurologic functions status of 0) ⑥ age, 18 and over ⑦
Beskrivning

Sign or Symptom Absent Metastatic malignant neoplasm to brain | RTOG Neurologic function Status | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0220650
UMLS CUI [2,1]
C1514695
UMLS CUI [2,2]
C0027767
UMLS CUI [2,3]
C0449438
UMLS CUI [3]
C0001779
ecog performance status 0-1 ⑧ written informed consent
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe co-morbid illness and/or active infections ② pregnant or lactating women
Beskrivning

Comorbidity Severe | Communicable Diseases | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
rtog neurologic function status of 1~4 ④ uncontrollable extracranial metastases
Beskrivning

RTOG Neurologic function Status | Neoplasm Metastasis Extracranial Control Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514695
UMLS CUI [1,2]
C0027767
UMLS CUI [1,3]
C0449438
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0580586
UMLS CUI [2,3]
C0243148
UMLS CUI [2,4]
C1272705
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01130766

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Metastatic malignant neoplasm to brain
Item
histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
boolean
C0007131 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Parenchymal Quantity MRI with contrast
Item
one to 4 intraparenchymal brain metastases by contrast-enhanced mri, meeting the following criteria:
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0202671 (UMLS CUI [1,4])
Tumor Circumscribed Well | Brain Edema CTCAE Grades
Item
1. well circumscribed tumor(s) with brain edema grade 0-1
boolean
C0027651 (UMLS CUI [1,1])
C1282914 (UMLS CUI [1,2])
C0205170 (UMLS CUI [1,3])
C1527311 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Diameter Maximum
Item
2. maximum diameter ≤ 3.0 cm
boolean
C1301886 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Complete excision Absent | Therapeutic radiology procedure | Metastatic Malignant Neoplasm to the Leptomeninges Absent MRI | Cerebrospinal Fluid Evaluation
Item
no prior complete resection of all known brain metastases or rt ④ no leptomeningeal metastases by mri or cerebrospinal fluid evaluation
boolean
C0220650 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C1704231 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0007806 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
Sign or Symptom Absent Metastatic malignant neoplasm to brain | RTOG Neurologic function Status | Age
Item
patients without any symptoms or signs from brain metastases (rtog neurologic functions status of 0) ⑥ age, 18 and over ⑦
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [1,3])
C1514695 (UMLS CUI [2,1])
C0027767 (UMLS CUI [2,2])
C0449438 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0-1 ⑧ written informed consent
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Severe | Communicable Diseases | Pregnancy | Breast Feeding
Item
severe co-morbid illness and/or active infections ② pregnant or lactating women
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
RTOG Neurologic function Status | Neoplasm Metastasis Extracranial Control Unsuccessful
Item
rtog neurologic function status of 1~4 ④ uncontrollable extracranial metastases
boolean
C1514695 (UMLS CUI [1,1])
C0027767 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0580586 (UMLS CUI [2,2])
C0243148 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
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