ID

43904

Beskrivning

Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00910572

Länk

https://clinicaltrials.gov/show/NCT00910572

Nyckelord

Versioner (2)
  1. 2017-07-29 2017-07-29 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00910572

Engelsk

Eligibility Hepatocellular Carcinoma NCT00910572

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of hcc confirmed by histology or non-invasive criteria (easl/aasld)
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
2. intermediate stage (bclc-b) hcc: patients with a large or multinodular hcc (single hcc > 5 cm or multiple hcc defined as > 3 nodules > 3 cm), a child pugh class a or b7 and no cancer related symptoms (ps=0-1).
Beskrivning

Liver carcinoma BCLC Stage | Liver carcinoma Large | Liver carcinoma Multinodular | Liver carcinoma Child-Pugh Classification | performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C3898888
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0549177
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0205416
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C4050412
UMLS CUI [5]
C1518965
3. advanced stage (bclc-c) hcc: patients with hepatic vascular involvement (at any tumor number and diameter), a child pugh class a or b7, no cancer related symptoms (ps=0-1) and absence of extra-hepatic tumor spread.
Beskrivning

Liver carcinoma BCLC Stage | Hepatic Involvement vascular | Liver carcinoma Child-Pugh Classification | performance status | Tumor Extrahepatic Spread Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C3898888
UMLS CUI [2,1]
C0441932
UMLS CUI [2,2]
C0005847
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C4050412
UMLS CUI [4]
C1518965
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1517058
UMLS CUI [5,3]
C0332261
UMLS CUI [5,4]
C0332197
4. cancer-related symptoms within the ecog 0-1 score
Beskrivning

Symptoms Malignant Neoplasm Related ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C1520224
5. liver function within child b-7 class
Beskrivning

Liver function Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
6. platelets > 50.000/µl
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
7. wbc > 1500/µl
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
8. ast/alt < 5 times the upper limit of normal (u/l)
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
9. creatinine < 2.0 mg /dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
10. no indication for any possible curative treatment after multidisciplinary assessment (resection, ablation, transplantation)
Beskrivning

Indication Absent Curative treatment | Multidisciplinary assessment | Excision | Ablation | Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1273390
UMLS CUI [2]
C0729737
UMLS CUI [3]
C0728940
UMLS CUI [4]
C0547070
UMLS CUI [5]
C0040732
11. signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. child-pugh class higher than b-7 at entry
Beskrivning

Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C4050412
2. ecog performance score ≥ 2 at entry
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
3. tumor volume ≥ 50% of liver volume
Beskrivning

Tumor Volume % volume Liver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475276
UMLS CUI [1,2]
C1690016
UMLS CUI [1,3]
C0023884
4. extrahepatic tumor spread
Beskrivning

Tumor Extrahepatic Spread

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C0332261
5. pulmonary insufficiency
Beskrivning

lung; insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1401064
6. life expectancy of less than 3 months due to hcc or less than 6 months due to any other disease
Beskrivning

Life Expectancy Due to Liver carcinoma | Life Expectancy Due to Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0012634
7. previous chemoembolization procedure (tace)
Beskrivning

Chemoembolization | Transarterial Chemoembolization

Datatyp

boolean

Alias
UMLS CUI [1]
C0796679
UMLS CUI [2]
C3539919
8. evidence on 99mtc-maa scan of vascular shunts that can not be corrected by angiographic coil embolization
Beskrivning

Vascular shunt Tc-99m MAA Scan | Embolization coil Angiography Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232350
UMLS CUI [1,2]
C0039415
UMLS CUI [1,3]
C0441633
UMLS CUI [2,1]
C0522644
UMLS CUI [2,2]
C0002978
UMLS CUI [2,3]
C1272705
9. evidence on 99mtc-maa scan of lung shunting, with a potential absorbed dose of radiation to the lungs > 30 gy
Beskrivning

Lung shunting Tc-99m MAA Scan | Radiation absorbed dose Lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0813207
UMLS CUI [1,3]
C0039415
UMLS CUI [1,4]
C0441633
UMLS CUI [2,1]
C0556643
UMLS CUI [2,2]
C0024109
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Similar models

Eligibility Hepatocellular Carcinoma NCT00910572

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
1. diagnosis of hcc confirmed by histology or non-invasive criteria (easl/aasld)
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma BCLC Stage | Liver carcinoma Large | Liver carcinoma Multinodular | Liver carcinoma Child-Pugh Classification | performance status
Item
2. intermediate stage (bclc-b) hcc: patients with a large or multinodular hcc (single hcc > 5 cm or multiple hcc defined as > 3 nodules > 3 cm), a child pugh class a or b7 and no cancer related symptoms (ps=0-1).
boolean
C2239176 (UMLS CUI [1,1])
C3898888 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0205416 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
C1518965 (UMLS CUI [5])
Liver carcinoma BCLC Stage | Hepatic Involvement vascular | Liver carcinoma Child-Pugh Classification | performance status | Tumor Extrahepatic Spread Absent
Item
3. advanced stage (bclc-c) hcc: patients with hepatic vascular involvement (at any tumor number and diameter), a child pugh class a or b7, no cancer related symptoms (ps=0-1) and absence of extra-hepatic tumor spread.
boolean
C2239176 (UMLS CUI [1,1])
C3898888 (UMLS CUI [1,2])
C0441932 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C4050412 (UMLS CUI [3,2])
C1518965 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
C0332261 (UMLS CUI [5,3])
C0332197 (UMLS CUI [5,4])
Symptoms Malignant Neoplasm Related ECOG performance status
Item
4. cancer-related symptoms within the ecog 0-1 score
boolean
C1457887 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1520224 (UMLS CUI [1,4])
Liver function Child-Pugh Classification
Item
5. liver function within child b-7 class
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Platelet Count measurement
Item
6. platelets > 50.000/µl
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
7. wbc > 1500/µl
boolean
C0023508 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
8. ast/alt < 5 times the upper limit of normal (u/l)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
9. creatinine < 2.0 mg /dl
boolean
C0201976 (UMLS CUI [1])
Indication Absent Curative treatment | Multidisciplinary assessment | Excision | Ablation | Transplantation
Item
10. no indication for any possible curative treatment after multidisciplinary assessment (resection, ablation, transplantation)
boolean
C3146298 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0729737 (UMLS CUI [2])
C0728940 (UMLS CUI [3])
C0547070 (UMLS CUI [4])
C0040732 (UMLS CUI [5])
Informed Consent
Item
11. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Child-Pugh Classification
Item
1. child-pugh class higher than b-7 at entry
boolean
C4050412 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance score ≥ 2 at entry
boolean
C1520224 (UMLS CUI [1])
Tumor Volume % volume Liver
Item
3. tumor volume ≥ 50% of liver volume
boolean
C0475276 (UMLS CUI [1,1])
C1690016 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
Tumor Extrahepatic Spread
Item
4. extrahepatic tumor spread
boolean
C0027651 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0332261 (UMLS CUI [1,3])
lung; insufficiency
Item
5. pulmonary insufficiency
boolean
C1401064 (UMLS CUI [1])
Life Expectancy Due to Liver carcinoma | Life Expectancy Due to Disease
Item
6. life expectancy of less than 3 months due to hcc or less than 6 months due to any other disease
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Chemoembolization | Transarterial Chemoembolization
Item
7. previous chemoembolization procedure (tace)
boolean
C0796679 (UMLS CUI [1])
C3539919 (UMLS CUI [2])
Vascular shunt Tc-99m MAA Scan | Embolization coil Angiography Unsuccessful
Item
8. evidence on 99mtc-maa scan of vascular shunts that can not be corrected by angiographic coil embolization
boolean
C0232350 (UMLS CUI [1,1])
C0039415 (UMLS CUI [1,2])
C0441633 (UMLS CUI [1,3])
C0522644 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Lung shunting Tc-99m MAA Scan | Radiation absorbed dose Lung
Item
9. evidence on 99mtc-maa scan of lung shunting, with a potential absorbed dose of radiation to the lungs > 30 gy
boolean
C0024109 (UMLS CUI [1,1])
C0813207 (UMLS CUI [1,2])
C0039415 (UMLS CUI [1,3])
C0441633 (UMLS CUI [1,4])
C0556643 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
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