ID

14593

Description

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

Link

https://clinicaltrials.gov/show/NCT02072356

Keywords

Versions (1)
  1. 4/22/16 4/22/16 -
Uploaded on

April 22, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

English

Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

1 forms  
Inclusion Criteria
Description

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
Description

intrahepatic malignancy

Data type

boolean

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

eastern cooperative oncology group

Data type

boolean

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

life expectancy

Data type

boolean

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

prior radiation, surgery or chemotherapy

Data type

boolean

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

written informed consent

Data type

boolean

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

ineligible for surgical resection

Data type

boolean

Alias
UMLS CUI [1]
C1512714
Exclusion Criteria
Description

Exclusion Criteria

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

aspartate aminotransferase

Data type

boolean

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

serum bilirubin

Data type

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
Description

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

Data type

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
Description

bleeding diathesis

Data type

boolean

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

Peripheral Vascular Diseases

Data type

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
Description

radiation

Data type

boolean

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

pulmonary insufficiency

Data type

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
Description

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

Data type

boolean

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

extrahepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C1517058
active uncontrolled infection
Description

active uncontrolled infection

Data type

boolean

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

medical or psychiatric illness

Data type

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
Description

Protocol Compliance

Data type

boolean

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

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Back to the top of the page

Similar models

Eligibility Adult Primary Hepatocellular Carcinoma NCT02072356

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial