ID

37730

Beskrivning

A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01065805

Länk

https://clinicaltrials.gov/show/NCT01065805

Nyckelord

Versioner (1)
  1. 2019-08-20 2019-08-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Brain Cancer NCT01065805

Engelsk

Eligibility Brain Cancer NCT01065805

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female greater than or equal to 16 years of age. if female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
Beskrivning

Age | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including ggm, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
Beskrivning

Recurrent lung cancer | Recurrent lung cancer Suspected | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of lung Suspected | Breast cancer recurrent | Breast cancer recurrent Suspected | Secondary malignant neoplasm of female breast | Secondary malignant neoplasm of female breast Suspected | Renal cell carcinoma recurrent | Renal cell carcinoma recurrent Suspected | Metastatic Renal Cell Cancer | Metastatic Renal Cell Cancer Suspected | Pancreatic carcinoma recurrent | Pancreatic carcinoma recurrent Suspected | Secondary malignant neoplasm of pancreas | Secondary malignant neoplasm of pancreas Suspected | Recurrent Brain Neoplasm | Recurrent Brain Neoplasm Suspected | Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Ganglioglioma | Oligodendroglioma | Metastatic malignant neoplasm to brain From Primary tumor | Gastrointestinal Neoplasms | Neuroendocrine Tumors | Carcinoid Tumor | Islet Cell Tumor | Lymphoma | Lesion Quantity Diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C0862802
UMLS CUI [2,1]
C0862802
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0153676
UMLS CUI [4,1]
C0153676
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0278493
UMLS CUI [6,1]
C0278493
UMLS CUI [6,2]
C0750491
UMLS CUI [7]
C0346993
UMLS CUI [8,1]
C0346993
UMLS CUI [8,2]
C0750491
UMLS CUI [9]
C0278679
UMLS CUI [10,1]
C0278679
UMLS CUI [10,2]
C0750491
UMLS CUI [11]
C0278678
UMLS CUI [12,1]
C0278678
UMLS CUI [12,2]
C0750491
UMLS CUI [13]
C0854777
UMLS CUI [14,1]
C0854777
UMLS CUI [14,2]
C0750491
UMLS CUI [15]
C0346976
UMLS CUI [16,1]
C0346976
UMLS CUI [16,2]
C0750491
UMLS CUI [17]
C0750977
UMLS CUI [18,1]
C0750977
UMLS CUI [18,2]
C0750491
UMLS CUI [19]
C0220650
UMLS CUI [20,1]
C0220650
UMLS CUI [20,2]
C0750491
UMLS CUI [21]
C0206716
UMLS CUI [22]
C0028945
UMLS CUI [23,1]
C0220650
UMLS CUI [23,2]
C1517320
UMLS CUI [23,3]
C0677930
UMLS CUI [24]
C0017185
UMLS CUI [25]
C0206754
UMLS CUI [26]
C0007095
UMLS CUI [27]
C0242363
UMLS CUI [28]
C0024299
UMLS CUI [29,1]
C0221198
UMLS CUI [29,2]
C1265611
UMLS CUI [29,3]
C1301886
biochemical parameters as measured are required to be within 5 times the normal limits for age.
Beskrivning

Parameters Biochemical | Normal limits Quantity Times | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205474
UMLS CUI [2,1]
C0442816
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1632851
UMLS CUI [3]
C0001779
able and willing to follow instruction and comply with the protocol
Beskrivning

Adherence Instructions | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C1442085
UMLS CUI [2]
C0525058
provide written informed consent prior to participation in the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
karnofsky performance scale score 50-100
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous removal of entire tumour
Beskrivning

Tumor removal Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0749736
UMLS CUI [1,2]
C0205156
biochemical parameters as measured outside 5 times the normal limits for age
Beskrivning

Parameters Biochemical | Normal limits Quantity Times failed | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205474
UMLS CUI [2,1]
C0442816
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1632851
UMLS CUI [2,4]
C0231175
UMLS CUI [3]
C0001779
unable or unwilling to follow instructions and comply with the protocol
Beskrivning

Adherence Instructions Unable | Protocol Compliance Unable | Adherence Instructions Unwilling | Protocol Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C1442085
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C1442085
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
unable or unwilling to provide written informed consent prior to participation in the study
Beskrivning

Informed Consent Unable | Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
karnofsky performance scale score < 50
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
nursing or pregnant females
Beskrivning

Breast Feeding | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
age less than 16 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Brain Cancer NCT01065805

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Childbearing Potential Pregnancy test negative
Item
male or female greater than or equal to 16 years of age. if female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
boolean
C0001779 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Recurrent lung cancer | Recurrent lung cancer Suspected | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of lung Suspected | Breast cancer recurrent | Breast cancer recurrent Suspected | Secondary malignant neoplasm of female breast | Secondary malignant neoplasm of female breast Suspected | Renal cell carcinoma recurrent | Renal cell carcinoma recurrent Suspected | Metastatic Renal Cell Cancer | Metastatic Renal Cell Cancer Suspected | Pancreatic carcinoma recurrent | Pancreatic carcinoma recurrent Suspected | Secondary malignant neoplasm of pancreas | Secondary malignant neoplasm of pancreas Suspected | Recurrent Brain Neoplasm | Recurrent Brain Neoplasm Suspected | Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Ganglioglioma | Oligodendroglioma | Metastatic malignant neoplasm to brain From Primary tumor | Gastrointestinal Neoplasms | Neuroendocrine Tumors | Carcinoid Tumor | Islet Cell Tumor | Lymphoma | Lesion Quantity Diameter
Item
patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including ggm, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
boolean
C0862802 (UMLS CUI [1])
C0862802 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0153676 (UMLS CUI [3])
C0153676 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0278493 (UMLS CUI [5])
C0278493 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0346993 (UMLS CUI [7])
C0346993 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0278679 (UMLS CUI [9])
C0278679 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C0278678 (UMLS CUI [11])
C0278678 (UMLS CUI [12,1])
C0750491 (UMLS CUI [12,2])
C0854777 (UMLS CUI [13])
C0854777 (UMLS CUI [14,1])
C0750491 (UMLS CUI [14,2])
C0346976 (UMLS CUI [15])
C0346976 (UMLS CUI [16,1])
C0750491 (UMLS CUI [16,2])
C0750977 (UMLS CUI [17])
C0750977 (UMLS CUI [18,1])
C0750491 (UMLS CUI [18,2])
C0220650 (UMLS CUI [19])
C0220650 (UMLS CUI [20,1])
C0750491 (UMLS CUI [20,2])
C0206716 (UMLS CUI [21])
C0028945 (UMLS CUI [22])
C0220650 (UMLS CUI [23,1])
C1517320 (UMLS CUI [23,2])
C0677930 (UMLS CUI [23,3])
C0017185 (UMLS CUI [24])
C0206754 (UMLS CUI [25])
C0007095 (UMLS CUI [26])
C0242363 (UMLS CUI [27])
C0024299 (UMLS CUI [28])
C0221198 (UMLS CUI [29,1])
C1265611 (UMLS CUI [29,2])
C1301886 (UMLS CUI [29,3])
Parameters Biochemical | Normal limits Quantity Times | Age
Item
biochemical parameters as measured are required to be within 5 times the normal limits for age.
boolean
C0449381 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0442816 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1632851 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Adherence Instructions | Protocol Compliance
Item
able and willing to follow instruction and comply with the protocol
boolean
C1510802 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
provide written informed consent prior to participation in the study
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance scale score 50-100
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor removal Previous
Item
previous removal of entire tumour
boolean
C0749736 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Parameters Biochemical | Normal limits Quantity Times failed | Age
Item
biochemical parameters as measured outside 5 times the normal limits for age
boolean
C0449381 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0442816 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1632851 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
C0001779 (UMLS CUI [3])
Adherence Instructions Unable | Protocol Compliance Unable | Adherence Instructions Unwilling | Protocol Compliance Unwilling
Item
unable or unwilling to follow instructions and comply with the protocol
boolean
C1510802 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1510802 (UMLS CUI [3,1])
C1442085 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide written informed consent prior to participation in the study
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
karnofsky performance scale score < 50
boolean
C0206065 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
nursing or pregnant females
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Age
Item
age less than 16 years
boolean
C0001779 (UMLS CUI [1])
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