ID

14593

Beskrivning

Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02072356

Länk

https://clinicaltrials.gov/show/NCT02072356

Nyckelord

Versioner (1)
  1. 2016-04-22 2016-04-22 -
Uppladdad den

22 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

Engelsk

Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of intrahepatic malignancy including but not limited to hcc; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (afp) and clinical findings
Beskrivning

intrahepatic malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0153448
eastern cooperative oncology group (ecog) performance status score 0 - 2
Beskrivning

eastern cooperative oncology group

Datatyp

boolean

Alias
UMLS CUI [1]
C1512162
life expectancy >= 3 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
> 4 weeks since prior radiation, surgery or chemotherapy
Beskrivning

prior radiation, surgery or chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
ineligible for surgical resection
Beskrivning

ineligible for surgical resection

Datatyp

boolean

Alias
UMLS CUI [1]
C1512714
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
aspartate aminotransferase (ast) or alanine aminotransferase (alt) > 5 times upper limit of normal (unl)
Beskrivning

aspartate aminotransferase

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Beskrivning

serum bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
Beskrivning

history of severe allergy or intolerance to any contrast media, narcotics, sedatives

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0027415
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0036557
bleeding diathesis, not correctable by usual forms of therapy
Beskrivning

bleeding diathesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
severe peripheral vascular disease that would preclude catheterization
Beskrivning

Peripheral Vascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0085096
evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs in a single treatment
Beskrivning

radiation

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
evidence of pulmonary insufficiency
Beskrivning

pulmonary insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1368022
evidence of any detectable technetium-99m macroaggregated serum albumin (tc-99m maa) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
Beskrivning

technetium-99m macroaggregated serum albumin (tc-99m maa)

Datatyp

boolean

Alias
UMLS CUI [1]
C1546126
significant extrahepatic disease representing an imminent life-threatening outcome
Beskrivning

extrahepatic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1517058
active uncontrolled infection
Beskrivning

active uncontrolled infection

Datatyp

boolean

Alias
UMLS CUI [1]
C3714514
significant underlying medical or psychiatric illness
Beskrivning

medical or psychiatric illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
co-morbid disease of condition that would preclude safe delivery of therasphere treatment or, in the judgment of the physician, place the patient at undue risk
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
pregnancy
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
intrahepatic malignancy
Item
diagnosis of intrahepatic malignancy including but not limited to hcc; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (afp) and clinical findings
boolean
C0153448 (UMLS CUI [1])
eastern cooperative oncology group
Item
eastern cooperative oncology group (ecog) performance status score 0 - 2
boolean
C1512162 (UMLS CUI [1])
life expectancy
Item
life expectancy >= 3 months
boolean
C0023671 (UMLS CUI [1])
prior radiation, surgery or chemotherapy
Item
> 4 weeks since prior radiation, surgery or chemotherapy
boolean
C0279134 (UMLS CUI [1])
written informed consent
Item
able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
ineligible for surgical resection
Item
ineligible for surgical resection
boolean
C1512714 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
aspartate aminotransferase
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) > 5 times upper limit of normal (unl)
boolean
C0201899 (UMLS CUI [1])
serum bilirubin
Item
serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
boolean
C1278039 (UMLS CUI [1])
history of severe allergy or intolerance to any contrast media, narcotics, sedatives
Item
history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0027415 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0036557 (UMLS CUI [3,2])
bleeding diathesis
Item
bleeding diathesis, not correctable by usual forms of therapy
boolean
C0005779 (UMLS CUI [1])
Peripheral Vascular Diseases
Item
severe peripheral vascular disease that would preclude catheterization
boolean
C0085096 (UMLS CUI [1])
radiation
Item
evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs in a single treatment
boolean
C1522449 (UMLS CUI [1])
pulmonary insufficiency
Item
evidence of pulmonary insufficiency
boolean
C1368022 (UMLS CUI [1])
technetium-99m macroaggregated serum albumin (tc-99m maa)
Item
evidence of any detectable technetium-99m macroaggregated serum albumin (tc-99m maa) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
boolean
C1546126 (UMLS CUI [1])
extrahepatic disease
Item
significant extrahepatic disease representing an imminent life-threatening outcome
boolean
C1517058 (UMLS CUI [1])
active uncontrolled infection
Item
active uncontrolled infection
boolean
C3714514 (UMLS CUI [1])
medical or psychiatric illness
Item
significant underlying medical or psychiatric illness
boolean
C0004936 (UMLS CUI [1])
Protocol Compliance
Item
co-morbid disease of condition that would preclude safe delivery of therasphere treatment or, in the judgment of the physician, place the patient at undue risk
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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