ID

36073

Beschrijving

Clinical Trial for GALNT14 Genotype - Guided, Sorafenib in Combination With TACE in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02504983

Link

https://clinicaltrials.gov/show/NCT02504983

Trefwoorden

Versies (2)
  1. 14-04-19 14-04-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02504983

Engels

Eligibility Hepatocellular Carcinoma NCT02504983

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of hcc:
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
cirrhotic subjects: clinical diagnosis by aasld criteria hcc can be defined in cirrhotic subjects by one imaging technique (ct scan, mri, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases, or two imaging techniques showing this radiological behaviour for nodules of 1-2cm in diameter cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria
Beschrijving

Study Subject Cirrhotic | Liver carcinoma | Nodule of liver Diameter Imaging Technique | Nodule of liver Diameter CT scan | Nodule of liver Diameter MRI | Nodule of liver Diameter Ultrasonography contrast | Nodule of liver Diameter Imaging Techniques Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439686
UMLS CUI [2]
C2239176
UMLS CUI [3,1]
C0745761
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0079595
UMLS CUI [4,1]
C0745761
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C0745761
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C0745761
UMLS CUI [6,2]
C1301886
UMLS CUI [6,3]
C0041618
UMLS CUI [6,4]
C0493823
UMLS CUI [7,1]
C0745761
UMLS CUI [7,2]
C1301886
UMLS CUI [7,3]
C0079595
UMLS CUI [7,4]
C1265611
non-cirrhotic subjects:
Beschrijving

Study Subject Non-cirrhotic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439687
for subjects without cirrhosis, histological confirmation is mandatory documentation of original biopsy for diagnosis is acceptable
Beschrijving

Liver Cirrhosis Absent | Histology Mandatory | Biopsy Acceptable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C1879533
2. never received tace/ chemotherapy/ radiotherapy or targeted agents prior to this study.
Beschrijving

TACE Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent | Targeted Therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C0332197
3. patients should be either in bclc clinical stage b (multinodular asymptomatic tumors without extra-hepatic spread or portal vein invasion) with or without unilateral secondary or tertiary branches of portal vein invasion. main portal vein invasion or extra-hepatic spread is not allowed.
Beschrijving

Hepatocellular Carcinoma by BCLC Stage | Tumor Multinodular Asymptomatic | Spread Extrahepatic Absent | Tumor Cell Invasion Portal vein Absent | Tumor Cell Invasion Portal vein Branch Unilateral | Tumor Cell Invasion Portal vein Branch Unilateral Absent | Tumor Cell Invasion Main portal vein Excluded | Spread Extrahepatic Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C3898888
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0205416
UMLS CUI [2,3]
C0231221
UMLS CUI [3,1]
C0332261
UMLS CUI [3,2]
C1517058
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C1269955
UMLS CUI [4,2]
C1305775
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1269955
UMLS CUI [5,2]
C1305775
UMLS CUI [5,3]
C1253959
UMLS CUI [5,4]
C0205092
UMLS CUI [6,1]
C1269955
UMLS CUI [6,2]
C1305775
UMLS CUI [6,3]
C1253959
UMLS CUI [6,4]
C0205092
UMLS CUI [6,5]
C0332197
UMLS CUI [7,1]
C1269955
UMLS CUI [7,2]
C1183135
UMLS CUI [7,3]
C0332196
UMLS CUI [8,1]
C0332261
UMLS CUI [8,2]
C1517058
UMLS CUI [8,3]
C0332196
4. child-pugh functional class a or b.
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
5. measurable disease using mrecist criteria. at least 1 measurable lesion must be present.
Beschrijving

Measurable Disease | Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
6. ecog performance status 0 to 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
7. age > 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
8. both men and women enrolled in this trial must use adequate birth control measures during the course of the trial and 4 weeks after the completion of trial
Beschrijving

Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
9. informed consent must be obtained prior to study initiation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
10. total bilirubin < 3.0 mg/dl with no evidence of biliary tract obstruction.
Beschrijving

Serum total bilirubin measurement | Biliary tract obstruction Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C0400979
UMLS CUI [2,2]
C0332197
11. serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 5 × upper limit of normal.
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
12. absolute neutrophil count > 1000/mm3; platelets ≧ 60x109/l.
Beschrijving

Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
13. serum creatinine < 2 x uln.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
14. antiviral treatment for hepatitis b or c is allowed except for interferon.
Beschrijving

Antiviral Therapy Hepatitis B | Antiviral Therapy Hepatitis C | Exception Interferon

Datatype

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3652465
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. bclc stage a.
Beschrijving

Hepatocellular Carcinoma by BCLC Stage

Datatype

boolean

Alias
UMLS CUI [1]
C3898888
2. presence of extrahepatic metastasis.
Beschrijving

Neoplasm Metastasis Extrahepatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
3. child-pugh score =c
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
4. significant cardiac disease.
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
5. serious bacteria infection requiring systemic antibiotics.
Beschrijving

Bacterial Infection Serious | Requirement Antibiotics for systemic use

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3540704
6. pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
7. expected non-compliance.
Beschrijving

Compliance behavior Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
8. uncontrolled illness including, but not limited to, ongoing infection, congestive hear failure, unstable angina pectoris, cardiac arryhythmia, or psychiatric illness.
Beschrijving

Illness Uncontrolled | Communicable Disease | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0004936
9. bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
Beschrijving

Bleeding esophageal varices | Bleeding gastric varices | Ligation Absent | Sclerosis injection therapy Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2]
C0267209
UMLS CUI [3,1]
C0023690
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0036429
UMLS CUI [4,2]
C0444472
UMLS CUI [4,3]
C0332197
10. subjects with known hiv infection.
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
11. ecog status > or = 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
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Similar models

Eligibility Hepatocellular Carcinoma NCT02504983

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
1. confirmed diagnosis of hcc:
boolean
C2239176 (UMLS CUI [1])
Study Subject Cirrhotic | Liver carcinoma | Nodule of liver Diameter Imaging Technique | Nodule of liver Diameter CT scan | Nodule of liver Diameter MRI | Nodule of liver Diameter Ultrasonography contrast | Nodule of liver Diameter Imaging Techniques Quantity
Item
cirrhotic subjects: clinical diagnosis by aasld criteria hcc can be defined in cirrhotic subjects by one imaging technique (ct scan, mri, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases, or two imaging techniques showing this radiological behaviour for nodules of 1-2cm in diameter cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria
boolean
C0681850 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
C0745761 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0079595 (UMLS CUI [3,3])
C0745761 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C0745761 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C0745761 (UMLS CUI [6,1])
C1301886 (UMLS CUI [6,2])
C0041618 (UMLS CUI [6,3])
C0493823 (UMLS CUI [6,4])
C0745761 (UMLS CUI [7,1])
C1301886 (UMLS CUI [7,2])
C0079595 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
Study Subject Non-cirrhotic
Item
non-cirrhotic subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0439687 (UMLS CUI [1,2])
Liver Cirrhosis Absent | Histology Mandatory | Biopsy Acceptable
Item
for subjects without cirrhosis, histological confirmation is mandatory documentation of original biopsy for diagnosis is acceptable
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0344441 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
TACE Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent | Targeted Therapy Absent
Item
2. never received tace/ chemotherapy/ radiotherapy or targeted agents prior to this study.
boolean
C3539919 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2985566 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hepatocellular Carcinoma by BCLC Stage | Tumor Multinodular Asymptomatic | Spread Extrahepatic Absent | Tumor Cell Invasion Portal vein Absent | Tumor Cell Invasion Portal vein Branch Unilateral | Tumor Cell Invasion Portal vein Branch Unilateral Absent | Tumor Cell Invasion Main portal vein Excluded | Spread Extrahepatic Excluded
Item
3. patients should be either in bclc clinical stage b (multinodular asymptomatic tumors without extra-hepatic spread or portal vein invasion) with or without unilateral secondary or tertiary branches of portal vein invasion. main portal vein invasion or extra-hepatic spread is not allowed.
boolean
C3898888 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0205416 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C0332261 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1269955 (UMLS CUI [4,1])
C1305775 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1269955 (UMLS CUI [5,1])
C1305775 (UMLS CUI [5,2])
C1253959 (UMLS CUI [5,3])
C0205092 (UMLS CUI [5,4])
C1269955 (UMLS CUI [6,1])
C1305775 (UMLS CUI [6,2])
C1253959 (UMLS CUI [6,3])
C0205092 (UMLS CUI [6,4])
C0332197 (UMLS CUI [6,5])
C1269955 (UMLS CUI [7,1])
C1183135 (UMLS CUI [7,2])
C0332196 (UMLS CUI [7,3])
C0332261 (UMLS CUI [8,1])
C1517058 (UMLS CUI [8,2])
C0332196 (UMLS CUI [8,3])
Child-Pugh Classification
Item
4. child-pugh functional class a or b.
boolean
C2347612 (UMLS CUI [1])
Measurable Disease | Measurable lesion Quantity
Item
5. measurable disease using mrecist criteria. at least 1 measurable lesion must be present.
boolean
C1513041 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
ECOG performance status
Item
6. ecog performance status 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Age
Item
7. age > 18 years
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods
Item
8. both men and women enrolled in this trial must use adequate birth control measures during the course of the trial and 4 weeks after the completion of trial
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
9. informed consent must be obtained prior to study initiation.
boolean
C0021430 (UMLS CUI [1])
Serum total bilirubin measurement | Biliary tract obstruction Absent
Item
10. total bilirubin < 3.0 mg/dl with no evidence of biliary tract obstruction.
boolean
C1278039 (UMLS CUI [1])
C0400979 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
11. serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 5 × upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Absolute neutrophil count | Platelet Count measurement
Item
12. absolute neutrophil count > 1000/mm3; platelets ≧ 60x109/l.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Creatinine measurement, serum
Item
13. serum creatinine < 2 x uln.
boolean
C0201976 (UMLS CUI [1])
Antiviral Therapy Hepatitis B | Antiviral Therapy Hepatitis C | Exception Interferon
Item
14. antiviral treatment for hepatitis b or c is allowed except for interferon.
boolean
C0280274 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3652465 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hepatocellular Carcinoma by BCLC Stage
Item
1. bclc stage a.
boolean
C3898888 (UMLS CUI [1])
Neoplasm Metastasis Extrahepatic
Item
2. presence of extrahepatic metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Child-Pugh Classification
Item
3. child-pugh score =c
boolean
C2347612 (UMLS CUI [1])
Heart Disease
Item
4. significant cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Bacterial Infection Serious | Requirement Antibiotics for systemic use
Item
5. serious bacteria infection requiring systemic antibiotics.
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3540704 (UMLS CUI [2,2])
Pregnancy
Item
6. pregnancy
boolean
C0032961 (UMLS CUI [1])
Compliance behavior Unlikely
Item
7. expected non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Illness Uncontrolled | Communicable Disease | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders
Item
8. uncontrolled illness including, but not limited to, ongoing infection, congestive hear failure, unstable angina pectoris, cardiac arryhythmia, or psychiatric illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Bleeding esophageal varices | Bleeding gastric varices | Ligation Absent | Sclerosis injection therapy Absent
Item
9. bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
boolean
C0155789 (UMLS CUI [1])
C0267209 (UMLS CUI [2])
C0023690 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036429 (UMLS CUI [4,1])
C0444472 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
HIV Infection
Item
10. subjects with known hiv infection.
boolean
C0019693 (UMLS CUI [1])
ECOG performance status
Item
11. ecog status > or = 2
boolean
C1520224 (UMLS CUI [1])
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