ID

40924

Description

Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT02182687

Link

https://clinicaltrials.gov/show/NCT02182687

Keywords

Versions (1)
  1. 6/6/20 6/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02182687

English

Eligibility Hepatocellular Carcinoma NCT02182687

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with hepatocellular carcinoma are eligible for this trial.
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
hepatocellular carcinoma is defined as having at least one of the following:
Description

Inclusion criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
biopsy proven hepatocellular carcinoma (hcc); or a discrete hepatic tumor(s) as defined by the barcelona (29) criteria for cirrhotic patients, >2cm with arterial hypervascularity and venous or delayed phase washout on ct or mri.
Description

Liver carcinoma Biopsy | Liver neoplasm discrete BCLC Stage | Tumor size | Arteries hypervascular | Phase Venous Washout | Phase Delayed Washout | Computed Tomography | MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0023903
UMLS CUI [2,2]
C0443299
UMLS CUI [2,3]
C3899974
UMLS CUI [3]
C0475440
UMLS CUI [4,1]
C0003842
UMLS CUI [4,2]
C1512560
UMLS CUI [5,1]
C0205390
UMLS CUI [5,2]
C0348013
UMLS CUI [5,3]
C1710661
UMLS CUI [6,1]
C0205390
UMLS CUI [6,2]
C0205421
UMLS CUI [6,3]
C1710661
UMLS CUI [7]
C0040405
UMLS CUI [8]
C0024485
patient is within milan criteria and "listed" for orthotopic liver transplantation.
Description

Ccriteria Fulfill Transplantation of liver | Patient on waiting list Orthotopic liver transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0023911
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0400447
patients must have a zubrod performance status of ≤2.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
patients must have a life expectancy of at least 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients must be 18 years of age or older. adult patients of all ages, both sexes and all races will be included in this study.
Description

Age | Adult | Gender | Racial group All

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C0034510
UMLS CUI [4,2]
C0444868
patients must be child-turcotte-pugh (ctp) class a or class b (≤ 7).
Description

Child-Pugh-Turcotte score

Data type

boolean

Alias
UMLS CUI [1]
C3854424
female patients within reproductive years may not be, nor become, pregnant during participation in this study. both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant.
Description

Childbearing Potential Pregnancy Absent | Females & males of reproductive potential Contraceptive methods | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430064
patients must have adequate organ function within 2 weeks of enrollment. bone marrow: platelets ≥30,000/mm3 renal: bun ≤40 mg/dl; creatinine ≤2.0 mg/dl hepatic: inr ≤ 1.5 or correctable by vitamin k, unless anti- coagulated for another medical reason bilirubin < 3 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis) patients uninvolved liver volume will be estimated and must be > 700ml.
Description

Organ function | Bone Marrow function | Platelet Count measurement | Renal function | Blood urea nitrogen measurement | Creatinine measurement, serum | Liver function | International Normalized Ratio | Vitamin K | Exception Anticoagulation Therapy | Serum total bilirubin measurement | Obstruction of biliary tree Absent | Biliary Tract Disease Absent | Primary sclerosing cholangitis Absent | Liver Volume

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0005845
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0232741
UMLS CUI [8]
C0525032
UMLS CUI [9]
C0042878
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0003281
UMLS CUI [11]
C1278039
UMLS CUI [12,1]
C0400979
UMLS CUI [12,2]
C0332197
UMLS CUI [13,1]
C0005424
UMLS CUI [13,2]
C0332197
UMLS CUI [14,1]
C0566602
UMLS CUI [14,2]
C0332197
UMLS CUI [15,1]
C0023884
UMLS CUI [15,2]
C0449468
patients must sign an informed consent form approved for this purpose by the institutional review board (irb) of the lahey hospital and medical center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients in a "special category" designated the public health service, including patients younger than 18, pregnant women, and prisoners.
Description

Age | Pregnancy | Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0033167
refractory ascites or ascites that requires paracentesis for management.
Description

Refractory ascites | Ascites Requirement Paracentesis

Data type

boolean

Alias
UMLS CUI [1]
C3532188
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0034115
patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size.
Description

Lesion solitary Size | Lesion discrete Quantity | Lesion Largest Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0443299
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0443228
UMLS CUI [3,3]
C0456389
known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
Description

Hypersensitivity Iodinated contrast dye Intravenous | Unresponsive to Prednisone Pretreatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0879373
UMLS CUI [1,3]
C1522726
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C3539076
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Similar models

Eligibility Hepatocellular Carcinoma NCT02182687

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
patients with hepatocellular carcinoma are eligible for this trial.
boolean
C2239176 (UMLS CUI [1])
Inclusion criteria Quantity Fulfill
Item
hepatocellular carcinoma is defined as having at least one of the following:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Liver carcinoma Biopsy | Liver neoplasm discrete BCLC Stage | Tumor size | Arteries hypervascular | Phase Venous Washout | Phase Delayed Washout | Computed Tomography | MRI
Item
biopsy proven hepatocellular carcinoma (hcc); or a discrete hepatic tumor(s) as defined by the barcelona (29) criteria for cirrhotic patients, >2cm with arterial hypervascularity and venous or delayed phase washout on ct or mri.
boolean
C2239176 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0023903 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
C3899974 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3])
C0003842 (UMLS CUI [4,1])
C1512560 (UMLS CUI [4,2])
C0205390 (UMLS CUI [5,1])
C0348013 (UMLS CUI [5,2])
C1710661 (UMLS CUI [5,3])
C0205390 (UMLS CUI [6,1])
C0205421 (UMLS CUI [6,2])
C1710661 (UMLS CUI [6,3])
C0040405 (UMLS CUI [7])
C0024485 (UMLS CUI [8])
Ccriteria Fulfill Transplantation of liver | Patient on waiting list Orthotopic liver transplant
Item
patient is within milan criteria and "listed" for orthotopic liver transplantation.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0023911 (UMLS CUI [1,3])
C0422768 (UMLS CUI [2,1])
C0400447 (UMLS CUI [2,2])
Zubrod Performance Status
Item
patients must have a zubrod performance status of ≤2.
boolean
C3714786 (UMLS CUI [1])
Life Expectancy
Item
patients must have a life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Age | Adult | Gender | Racial group All
Item
patients must be 18 years of age or older. adult patients of all ages, both sexes and all races will be included in this study.
boolean
C0001779 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0034510 (UMLS CUI [4,1])
C0444868 (UMLS CUI [4,2])
Child-Pugh-Turcotte score
Item
patients must be child-turcotte-pugh (ctp) class a or class b (≤ 7).
boolean
C3854424 (UMLS CUI [1])
Childbearing Potential Pregnancy Absent | Females & males of reproductive potential Contraceptive methods | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test
Item
female patients within reproductive years may not be, nor become, pregnant during participation in this study. both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant.
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430064 (UMLS CUI [4,2])
Organ function | Bone Marrow function | Platelet Count measurement | Renal function | Blood urea nitrogen measurement | Creatinine measurement, serum | Liver function | International Normalized Ratio | Vitamin K | Exception Anticoagulation Therapy | Serum total bilirubin measurement | Obstruction of biliary tree Absent | Biliary Tract Disease Absent | Primary sclerosing cholangitis Absent | Liver Volume
Item
patients must have adequate organ function within 2 weeks of enrollment. bone marrow: platelets ≥30,000/mm3 renal: bun ≤40 mg/dl; creatinine ≤2.0 mg/dl hepatic: inr ≤ 1.5 or correctable by vitamin k, unless anti- coagulated for another medical reason bilirubin < 3 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis) patients uninvolved liver volume will be estimated and must be > 700ml.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0005845 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0232741 (UMLS CUI [7])
C0525032 (UMLS CUI [8])
C0042878 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0003281 (UMLS CUI [10,2])
C1278039 (UMLS CUI [11])
C0400979 (UMLS CUI [12,1])
C0332197 (UMLS CUI [12,2])
C0005424 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
C0566602 (UMLS CUI [14,1])
C0332197 (UMLS CUI [14,2])
C0023884 (UMLS CUI [15,1])
C0449468 (UMLS CUI [15,2])
Informed Consent
Item
patients must sign an informed consent form approved for this purpose by the institutional review board (irb) of the lahey hospital and medical center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age | Pregnancy | Prisoners
Item
patients in a "special category" designated the public health service, including patients younger than 18, pregnant women, and prisoners.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0033167 (UMLS CUI [3])
Refractory ascites | Ascites Requirement Paracentesis
Item
refractory ascites or ascites that requires paracentesis for management.
boolean
C3532188 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0034115 (UMLS CUI [2,3])
Lesion solitary Size | Lesion discrete Quantity | Lesion Largest Size
Item
patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size.
boolean
C0221198 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C0443228 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
Hypersensitivity Iodinated contrast dye Intravenous | Unresponsive to Prednisone Pretreatment
Item
known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
boolean
C0020517 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
C0205269 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C3539076 (UMLS CUI [2,3])
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