ID

29814

Description

TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01349075

Link

https://clinicaltrials.gov/show/NCT01349075

Keywords

Versions (1)
  1. 4/21/18 4/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01349075

English

Eligibility Hepatocellular Carcinoma NCT01349075

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver
Description

Age | Racial group Any | Gender | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3]
C0079399
UMLS CUI [4]
C2239176
patients who are able to give informed consent, will be eligible.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have an ecog performance status score of < or = 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must have a life expectancy of > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
non-pregnant with an acceptable contraception in premenopausal women
Description

Pregnancy Absent | Premenopausal state Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0700589
patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy
Description

Timespan Since Prior radiation therapy | Timespan Since Operative Surgical Procedures | Timespan Post Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0279134
UMLS CUI [2,1]
C0872291
UMLS CUI [2,2]
C1711239
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0872291
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to angiography and selective visceral catheterization
Description

Medical contraindication Angiography | Medical contraindication Catheterization Visceral Selected

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002978
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0007430
UMLS CUI [2,3]
C0442045
UMLS CUI [2,4]
C1707391
evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) per treatment of radiation to the lungs
Description

Therapeutic radiology procedure Dosage Lung

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0024109
evidence of any detectable tc-99m maa flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
Description

Tc-99m MAA Flow Stomach Detectable | Tc-99m MAA Flow Duodenum Detectable | Angiography | Catheter placement Distal Vessel Gastric

Data type

boolean

Alias
UMLS CUI [1,1]
C0039415
UMLS CUI [1,2]
C0806140
UMLS CUI [1,3]
C0038351
UMLS CUI [1,4]
C3830527
UMLS CUI [2,1]
C0039415
UMLS CUI [2,2]
C0806140
UMLS CUI [2,3]
C0013303
UMLS CUI [2,4]
C3830527
UMLS CUI [3]
C0002978
UMLS CUI [4,1]
C0883301
UMLS CUI [4,2]
C0205108
UMLS CUI [4,3]
C0005847
UMLS CUI [4,4]
C1704242
significant extrahepatic disease representing an imminent life-threatening outcome
Description

Disease Extrahepatic Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C2826244
severe liver dysfunction or pulmonary insufficiency
Description

Liver Dysfunction Severe | Lung insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1401064
UMLS CUI [2,2]
C0205082
active uncontrolled infection
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
significant underlying medical or psychiatric illness
Description

Illness Significant | Mental disorders Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of therasphere treatment and place the patient at undue risk.
Description

Diarrhea Pre-existing | Pre-existing disease | Comorbidity Excludes Therasphere | Comorbidity At risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0521987
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1135147
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0030705
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Similar models

Eligibility Hepatocellular Carcinoma NCT01349075

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Racial group Any | Gender | Liver carcinoma
Item
patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
C2239176 (UMLS CUI [4])
Informed Consent
Item
patients who are able to give informed consent, will be eligible.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
patients must have an ecog performance status score of < or = 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
must have a life expectancy of > 3 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy Absent | Premenopausal state Contraceptive methods
Item
non-pregnant with an acceptable contraception in premenopausal women
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Timespan Since Prior radiation therapy | Timespan Since Operative Surgical Procedures | Timespan Post Chemotherapy
Item
patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy
boolean
C0872291 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0872291 (UMLS CUI [2,1])
C1711239 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0872291 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Angiography | Medical contraindication Catheterization Visceral Selected
Item
contraindications to angiography and selective visceral catheterization
boolean
C1301624 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0007430 (UMLS CUI [2,2])
C0442045 (UMLS CUI [2,3])
C1707391 (UMLS CUI [2,4])
Therapeutic radiology procedure Dosage Lung
Item
evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) per treatment of radiation to the lungs
boolean
C1522449 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,3])
Tc-99m MAA Flow Stomach Detectable | Tc-99m MAA Flow Duodenum Detectable | Angiography | Catheter placement Distal Vessel Gastric
Item
evidence of any detectable tc-99m maa flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
boolean
C0039415 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
C0038351 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C0039415 (UMLS CUI [2,1])
C0806140 (UMLS CUI [2,2])
C0013303 (UMLS CUI [2,3])
C3830527 (UMLS CUI [2,4])
C0002978 (UMLS CUI [3])
C0883301 (UMLS CUI [4,1])
C0205108 (UMLS CUI [4,2])
C0005847 (UMLS CUI [4,3])
C1704242 (UMLS CUI [4,4])
Disease Extrahepatic Life Threatening
Item
significant extrahepatic disease representing an imminent life-threatening outcome
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
Liver Dysfunction Severe | Lung insufficiency Severe
Item
severe liver dysfunction or pulmonary insufficiency
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1401064 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Illness Significant | Mental disorders Significant
Item
significant underlying medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Diarrhea Pre-existing | Pre-existing disease | Comorbidity Excludes Therasphere | Comorbidity At risk Patient
Item
patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of therasphere treatment and place the patient at undue risk.
boolean
C0011991 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521987 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1135147 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
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