ID

39786

Description

HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01387932

Link

https://clinicaltrials.gov/show/NCT01387932

Keywords

Versions (2)
  1. 2/19/20 2/19/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 19, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01387932

English

Eligibility Hepatocellular Carcinoma NCT01387932

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet all of the following inclusion criteria in order to be entered into the study:
Description

Inclusion criteria All Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. age 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patient has signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
i. histological confirmation ii. magnetic resonance imaging (mri) result with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
Description

Confirmed by Histology | Liver lesion Size Quantity MRI | Liver Cirrhosis | Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C0344441
UMLS CUI [2,1]
C0577053
UMLS CUI [2,2]
C0449453
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3]
C0023890
UMLS CUI [4]
C0524909
iii. contrast enhanced computed tomography (ct) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
Description

Liver lesion Size Quantity CT with Contrast | Liver Cirrhosis | Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0449453
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0742919
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0524909
d. patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
Description

Patient Inappropriate Excision | Patient Inappropriate Percutaneous Catheter Ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0162560
patients not suitable for ablation due to lesion location may be enrolled
Description

Patient Inappropriate Ablation | Etiology Lesion Location

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0547070
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C1515974
e. patient must meet at least one of the following criteria:
Description

Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
i. stage child-pugh b 7 ii. recurrent hcc iii.performance status ecog 1
Description

Child-Pugh Classification | Recurrent Hepatocellular Carcinoma | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2]
C0861876
UMLS CUI [3]
C1520224
f. patient has a life expectancy of at least 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
g. absence of occlusive thrombus to the main portal trunk
Description

Absence Occlusive thrombus Main portal venous trunk

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0333203
UMLS CUI [1,3]
C1183135
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if patients meet any of the following criteria they may not be entered into the study:
Description

Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. current or previous treatment with chemo- or radiation therapy or sorafenib
Description

Chemotherapy | Therapeutic radiology procedure | sorafenib

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1516119
2. previous treatment with any form of transarterial embolization for hcc
Description

Transarterial embolization Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3163695
UMLS CUI [1,2]
C2239176
3. patients with current or history of any other cancer except non-melanomatous skin cancer
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
4. female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
Description

Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
5. performance status ecog > 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. child-pugh scores >7
Description

Child-Pugh - Total Score

Data type

boolean

Alias
UMLS CUI [1]
C4055253
7. active gastrointestinal bleeding
Description

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
8. evidence of uncorrectable bleeding diathesis
Description

Bleeding tendency | Correction Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C1272705
9. extra-hepatic spread of the hcc
Description

Liver carcinoma Spread Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C1517058
10. total bilirubin > 3 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
11. >50% tumor involvement of the liver
Description

Liver Percentage Involvement with Tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0027651
12. infiltrative or diffuse hcc
Description

Liver carcinoma Infiltrating | Liver carcinoma Diffuse

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332448
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205219
13. encephalopathy not adequately controlled medically
Description

Encephalopathy Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C3853134
14. presence of ascites not controlled medically
Description

Ascites Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
15. presence of medically relevant localized or systemic infection, other than hepatitis b, c, d, e or g
Description

Focal Infection | Sepsis | Exception Hepatitis B | Exception Hepatitis C | Exception Hepatitis D | Exception Hepatitis E | Exception Hepatitis G

Data type

boolean

Alias
UMLS CUI [1]
C0016397
UMLS CUI [2]
C0243026
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019196
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0011226
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0085293
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0814152
16. any contraindication for mri (eg. metallic implants)
Description

Medical contraindication MRI | Metallic implant

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3693688
17. allergy to contrast media that cannot be managed with prophylaxis
Description

Contrast media allergy | Prophylactic treatment Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C1272705
18. allergy to iodized oil
Description

Hypersensitivity Iodized Oil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021972
19. any contraindication to arteriography
Description

Medical contraindication Arteriography

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003844
20. any contraindication for doxorubicin administration, including the following:
Description

Medical contraindication Doxorubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013089
i. white blood cell count (wbc) <3000 cells/mm₃
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
ii. absolute neutrophil <1500 cells/mm₃
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
iii. cardiac ejection fraction <50%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
iv. other condition deemed exclusionary by physician
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
u. any contraindication for hepatic embolization, including the following:
Description

Medical contraindication Hepatic embolisation

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0744813
i. porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
Description

Portasystemic shunt | Arteriovenous fistula

Data type

boolean

Alias
UMLS CUI [1]
C0948900
UMLS CUI [2]
C0003855
ii. hepatofugal blood flow
Description

Hepatofugal flow

Data type

boolean

Alias
UMLS CUI [1]
C4086746
iii. serum creatinine > 2mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
iv. uncorrectable impaired clotting
Description

Clotting Impaired | Correction Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C1272705
1. platelet <50,000/mm₃
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
2. international normalized ratio (inr) > 1.4
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
3. activated prothrombin time (aptt) less than 21 or greater than 40
Description

Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0030605
v. ast > 5x upper limit of normal for lab
Description

Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
vi. alt > 5x upper limit of normal for lab
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
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Similar models

Eligibility Hepatocellular Carcinoma NCT01387932

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria All Fulfill
Item
patients must meet all of the following inclusion criteria in order to be entered into the study:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
1. age 18 or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. patient has signed informed consent
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma
Item
3. patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
boolean
C2239176 (UMLS CUI [1])
Confirmed by Histology | Liver lesion Size Quantity MRI | Liver Cirrhosis | Hepatitis B, Chronic
Item
i. histological confirmation ii. magnetic resonance imaging (mri) result with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
boolean
C0521093 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0577053 (UMLS CUI [2,1])
C0449453 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0023890 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Liver lesion Size Quantity CT with Contrast | Liver Cirrhosis | Hepatitis B, Chronic
Item
iii. contrast enhanced computed tomography (ct) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
boolean
C0577053 (UMLS CUI [1,1])
C0449453 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0742919 (UMLS CUI [1,4])
C0023890 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
Patient Inappropriate Excision | Patient Inappropriate Percutaneous Catheter Ablation
Item
d. patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0162560 (UMLS CUI [2,3])
Patient Inappropriate Ablation | Etiology Lesion Location
Item
patients not suitable for ablation due to lesion location may be enrolled
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0547070 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
Criteria Quantity Fulfill
Item
e. patient must meet at least one of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Child-Pugh Classification | Recurrent Hepatocellular Carcinoma | ECOG performance status
Item
i. stage child-pugh b 7 ii. recurrent hcc iii.performance status ecog 1
boolean
C2347612 (UMLS CUI [1])
C0861876 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
Life Expectancy
Item
f. patient has a life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Absence Occlusive thrombus Main portal venous trunk
Item
g. absence of occlusive thrombus to the main portal trunk
boolean
C0332197 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C1183135 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
if patients meet any of the following criteria they may not be entered into the study:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Chemotherapy | Therapeutic radiology procedure | sorafenib
Item
1. current or previous treatment with chemo- or radiation therapy or sorafenib
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1516119 (UMLS CUI [3])
Transarterial embolization Liver carcinoma
Item
2. previous treatment with any form of transarterial embolization for hcc
boolean
C3163695 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma
Item
3. patients with current or history of any other cancer except non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent
Item
4. female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
ECOG performance status
Item
5. performance status ecog > 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh - Total Score
Item
6. child-pugh scores >7
boolean
C4055253 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
7. active gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
Bleeding tendency | Correction Unsuccessful
Item
8. evidence of uncorrectable bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Liver carcinoma Spread Extrahepatic
Item
9. extra-hepatic spread of the hcc
boolean
C2239176 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Serum total bilirubin measurement
Item
10. total bilirubin > 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Liver Percentage Involvement with Tumor
Item
11. >50% tumor involvement of the liver
boolean
C0023884 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0027651 (UMLS CUI [1,4])
Liver carcinoma Infiltrating | Liver carcinoma Diffuse
Item
12. infiltrative or diffuse hcc
boolean
C2239176 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0205219 (UMLS CUI [2,2])
Encephalopathy Poorly controlled
Item
13. encephalopathy not adequately controlled medically
boolean
C0085584 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Ascites Uncontrolled
Item
14. presence of ascites not controlled medically
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Focal Infection | Sepsis | Exception Hepatitis B | Exception Hepatitis C | Exception Hepatitis D | Exception Hepatitis E | Exception Hepatitis G
Item
15. presence of medically relevant localized or systemic infection, other than hepatitis b, c, d, e or g
boolean
C0016397 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0011226 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0085293 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0814152 (UMLS CUI [7,2])
Medical contraindication MRI | Metallic implant
Item
16. any contraindication for mri (eg. metallic implants)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
Contrast media allergy | Prophylactic treatment Unsuccessful
Item
17. allergy to contrast media that cannot be managed with prophylaxis
boolean
C0570562 (UMLS CUI [1])
C0199176 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Hypersensitivity Iodized Oil
Item
18. allergy to iodized oil
boolean
C0020517 (UMLS CUI [1,1])
C0021972 (UMLS CUI [1,2])
Medical contraindication Arteriography
Item
19. any contraindication to arteriography
boolean
C1301624 (UMLS CUI [1,1])
C0003844 (UMLS CUI [1,2])
Medical contraindication Doxorubicin
Item
20. any contraindication for doxorubicin administration, including the following:
boolean
C1301624 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
i. white blood cell count (wbc) <3000 cells/mm₃
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
ii. absolute neutrophil <1500 cells/mm₃
boolean
C0948762 (UMLS CUI [1])
Cardiac ejection fraction
Item
iii. cardiac ejection fraction <50%
boolean
C0232174 (UMLS CUI [1])
Exclusion Criteria Additional
Item
iv. other condition deemed exclusionary by physician
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Medical contraindication Hepatic embolisation
Item
u. any contraindication for hepatic embolization, including the following:
boolean
C1301624 (UMLS CUI [1,1])
C0744813 (UMLS CUI [1,2])
Portasystemic shunt | Arteriovenous fistula
Item
i. porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
boolean
C0948900 (UMLS CUI [1])
C0003855 (UMLS CUI [2])
Hepatofugal flow
Item
ii. hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Creatinine measurement, serum
Item
iii. serum creatinine > 2mg/dl
boolean
C0201976 (UMLS CUI [1])
Clotting Impaired | Correction Unsuccessful
Item
iv. uncorrectable impaired clotting
boolean
C0005778 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Platelet Count measurement
Item
1. platelet <50,000/mm₃
boolean
C0032181 (UMLS CUI [1])
International Normalized Ratio
Item
2. international normalized ratio (inr) > 1.4
boolean
C0525032 (UMLS CUI [1])
Activated Partial Thromboplastin Time measurement
Item
3. activated prothrombin time (aptt) less than 21 or greater than 40
boolean
C0030605 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
v. ast > 5x upper limit of normal for lab
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
vi. alt > 5x upper limit of normal for lab
boolean
C0151905 (UMLS CUI [1])
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