ID

44572

Description

Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02513199

Link

https://clinicaltrials.gov/show/NCT02513199

Keywords

Versions (2)
  1. 2/25/20 2/25/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

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 Hepatocellular Carcinoma NCT02513199

English

Eligibility Hepatocellular Carcinoma NCT02513199

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be diagnosed with hcc either pathologically or by the american association for the study of liver diseases (aasld) radiographic criteria (bruix hepatology 2011). the criteria specifies ct or mri intense arterial uptake followed by "washout" of contrast in the venous-delayed phases. any atypical lesions must be confirmed by biopsy.
Description

Liver carcinoma CT | Liver carcinoma MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0024485
a single liver lesion with tumor size ≥ 3 cm as defined as maximal diameter in the axial dimension on mri. included in the measurement are both enhancing and non-enhancing components of the lesion.
Description

Single lesion Liver | Tumor size Diameter MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0577304
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0024485
maximum tumor size of 7 cm as defined as maximal diameter in the axial dimension on mri.
Description

Tumor size Maximum | Diameter Maximal MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0806909
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C0024485
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
child-pugh class a or b7 without ascites
Description

Child-Pugh Classification | Ascites Absent

Data type

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0332197
ecog score 0
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
no prior treatment of current hcc. however, recurrent hcc after resection may be included.
Description

Prior Therapy Absent Liver carcinoma | Recurrent Hepatocellular Carcinoma Post Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C0861876
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0728940
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy which will be assessed via pregnancy test prior to tace and repeated prior to sbrt.
Description

Pregnancy | Pregnancy Test prior to Transarterial Chemoembolization | Pregnancy Test prior to Stereotactic Body Radiation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032976
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C3539919
UMLS CUI [3,1]
C0032976
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C3896609
metastatic disease outside of the liver
Description

Neoplasm Metastasis Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
vascular invasion as evidenced by vessel occlusion or radiographic evidence of tumor thrombus.
Description

Vascular Invasion | Vessel occlusion | Tumor thrombus Radiography

Data type

boolean

Alias
UMLS CUI [1]
C0521157
UMLS CUI [2]
C1386685
UMLS CUI [3,1]
C3163918
UMLS CUI [3,2]
C0034571
contraindications to mri, including claustrophobia, metallic implants, and pacemakers
Description

Medical contraindication MRI | Claustrophobia | Metallic implant | Pacemakers

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0810633
tumor for which adequate radiation dosage cannot be safely delivered (see dose constraints below)
Description

Radiation Dosage Inadequate Tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0034524
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0027651
prior therapeutic radiation therapy to the abdomen and/or lower thorax as defined as below the carina to the pelvic inlet.
Description

Radiotherapy to abdomen | Radiotherapy to thorax Part Lower

Data type

boolean

Alias
UMLS CUI [1]
C1997554
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0441994
inability to provide informed consent based on persistent lack of understanding, inability to find adequate translation, impaired mental status such as mental retardation, drug induced, or traumatic brain injury.
Description

Informed Consent Unable | Comprehension Lacking | Mental impairment | Mental Retardation Drug-induced | Traumatic Brain Injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0332268
UMLS CUI [3]
C0683322
UMLS CUI [4,1]
C0025362
UMLS CUI [4,2]
C0458082
UMLS CUI [5]
C0876926
multiple liver tumors making the patient a bclc stage b
Description

Liver neoplasms multiple BCLC Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0023903
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C3899974
prior treatment, except for surgical resection, to the lesion being targeted in the protocol.
Description

Prior Therapy Target Lesion | Exception Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2986546
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0728940
Back to the top of the page

Similar models

Eligibility Hepatocellular Carcinoma NCT02513199

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma CT | Liver carcinoma MRI
Item
participants must be diagnosed with hcc either pathologically or by the american association for the study of liver diseases (aasld) radiographic criteria (bruix hepatology 2011). the criteria specifies ct or mri intense arterial uptake followed by "washout" of contrast in the venous-delayed phases. any atypical lesions must be confirmed by biopsy.
boolean
C2239176 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Single lesion Liver | Tumor size Diameter MRI
Item
a single liver lesion with tumor size ≥ 3 cm as defined as maximal diameter in the axial dimension on mri. included in the measurement are both enhancing and non-enhancing components of the lesion.
boolean
C0577304 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Tumor size Maximum | Diameter Maximal MRI
Item
maximum tumor size of 7 cm as defined as maximal diameter in the axial dimension on mri.
boolean
C0475440 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Child-Pugh Classification | Ascites Absent
Item
child-pugh class a or b7 without ascites
boolean
C4050412 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog score 0
boolean
C1520224 (UMLS CUI [1])
Prior Therapy Absent Liver carcinoma | Recurrent Hepatocellular Carcinoma Post Excision
Item
no prior treatment of current hcc. however, recurrent hcc after resection may be included.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0861876 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy Test prior to Transarterial Chemoembolization | Pregnancy Test prior to Stereotactic Body Radiation Therapy
Item
pregnancy which will be assessed via pregnancy test prior to tace and repeated prior to sbrt.
boolean
C0032961 (UMLS CUI [1])
C0032976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3539919 (UMLS CUI [2,3])
C0032976 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C3896609 (UMLS CUI [3,3])
Neoplasm Metastasis Extrahepatic
Item
metastatic disease outside of the liver
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Vascular Invasion | Vessel occlusion | Tumor thrombus Radiography
Item
vascular invasion as evidenced by vessel occlusion or radiographic evidence of tumor thrombus.
boolean
C0521157 (UMLS CUI [1])
C1386685 (UMLS CUI [2])
C3163918 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
Medical contraindication MRI | Claustrophobia | Metallic implant | Pacemakers
Item
contraindications to mri, including claustrophobia, metallic implants, and pacemakers
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0810633 (UMLS CUI [4])
Radiation Dosage Inadequate Tumor
Item
tumor for which adequate radiation dosage cannot be safely delivered (see dose constraints below)
boolean
C0034524 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Radiotherapy to abdomen | Radiotherapy to thorax Part Lower
Item
prior therapeutic radiation therapy to the abdomen and/or lower thorax as defined as below the carina to the pelvic inlet.
boolean
C1997554 (UMLS CUI [1])
C4038705 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0441994 (UMLS CUI [2,3])
Informed Consent Unable | Comprehension Lacking | Mental impairment | Mental Retardation Drug-induced | Traumatic Brain Injury
Item
inability to provide informed consent based on persistent lack of understanding, inability to find adequate translation, impaired mental status such as mental retardation, drug induced, or traumatic brain injury.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0683322 (UMLS CUI [3])
C0025362 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
C0876926 (UMLS CUI [5])
Liver neoplasms multiple BCLC Stage
Item
multiple liver tumors making the patient a bclc stage b
boolean
C0023903 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C3899974 (UMLS CUI [1,3])
Prior Therapy Target Lesion | Exception Excision
Item
prior treatment, except for surgical resection, to the lesion being targeted in the protocol.
boolean
C1514463 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
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