ID

29822

Beskrivning

Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01481805

Länk

https://clinicaltrials.gov/show/NCT01481805

Nyckelord

Versioner (2)
  1. 2018-04-21 2018-04-21 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01481805

Engelsk

Eligibility Hepatocellular Carcinoma NCT01481805

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed hepatocellular carcinoma (hcc) or a combination of radiologically compatible finding to hcc, alpha-fetoprotein > 400ng/ml and liver cirrhosis
Beskrivning

Liver carcinoma | Radiology Consistent with Liver carcinoma | Radiology Consistent with Alpha one fetoprotein measurement | Radiology Consistent with Liver Cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0043299
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C0043299
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0201539
UMLS CUI [4,1]
C0043299
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C0023890
inoperable disease as defined by (localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin or presence of extra-hepatic disease or main portal vein or hepatic vein involvement (invasion or tumor thrombus) or the hcc must not be amenable to intra-arterial therapy or local ablative therapy)
Beskrivning

Disease Inoperable | Disease Extrahepatic | Main portal vein Involvement | Main portal vein Invasion | Main portal vein Tumor Thrombus | Hepatic vein Involvement | Hepatic vein Invasion | Hepatic vein Tumor Thrombus | Liver carcinoma Inappropriate Therapeutic procedure Intraarterial | Liver carcinoma Inappropriate Ablation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1517058
UMLS CUI [3,1]
C1183135
UMLS CUI [3,2]
C1314939
UMLS CUI [4,1]
C1183135
UMLS CUI [4,2]
C1269955
UMLS CUI [5,1]
C1183135
UMLS CUI [5,2]
C0027651
UMLS CUI [5,3]
C0087086
UMLS CUI [6,1]
C0019155
UMLS CUI [6,2]
C1314939
UMLS CUI [7,1]
C0019155
UMLS CUI [7,2]
C1269955
UMLS CUI [8,1]
C0019155
UMLS CUI [8,2]
C0027651
UMLS CUI [8,3]
C0087086
UMLS CUI [9,1]
C2239176
UMLS CUI [9,2]
C1548788
UMLS CUI [9,3]
C0087111
UMLS CUI [9,4]
C0694634
UMLS CUI [10,1]
C2239176
UMLS CUI [10,2]
C1548788
UMLS CUI [10,3]
C0547070
minimum life expectancy of 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
age > 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of ≤ 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Beskrivning

Bone Marrow function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
(hemoglobin > 9.0 g/dl,absolute neutrophil count>1,500/mm3, platelet count>75,000/μl,total bilirubin < 1.5 times the upper limit of normal,alt and ast < 5 x upper limit of normal,albumin ≥ 3g/dl,pt-inr/ptt < 1.5 x upper limit of normal,serum creatinine < 1.5 x upper limit of normal or creatinine clearance ≥ 50ml/min)
Beskrivning

Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Albumin measurement | Prothrombin time international normalized ratio (PT-INR) | Activated Partial Thromboplastin Time measurement | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201838
UMLS CUI [8]
C1821762
UMLS CUI [9]
C0030605
UMLS CUI [10]
C0201976
UMLS CUI [11]
C0373595
signed and dated informed consent before the start of specific protocol procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
fna will be performed in patients with feasible biopsy site
Beskrivning

Fine needle aspiration biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C1510483
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated cirrhosis or stage c (index > 10) according to the child-pugh classification
Beskrivning

Decompensated cirrhosis | Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C2347612
other concomitant anticancer agent, including tamoxifen and interferon
Beskrivning

Antineoplastic Agents | Tamoxifen | Interferon

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0039286
UMLS CUI [3]
C3652465
active clinically serious infections (> grade 2 ctcae version 3.0)
Beskrivning

Communicable Diseases Serious CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
history of organ allograft
Beskrivning

Organ Allograft

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
patients with evidence or history of bleeding diasthesis
Beskrivning

Bleeding tendency

Datatyp

boolean

Alias
UMLS CUI [1]
C1458140
patients undergoing renal dialysis
Beskrivning

Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
radiotherapy during study or within 4 weeks of start of study drug.
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
prior exposure to the study drug.
Beskrivning

Exposure to Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Beskrivning

Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C0037403
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C1261322
UMLS CUI [8,4]
C0683954
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Similar models

Eligibility Hepatocellular Carcinoma NCT01481805

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Radiology Consistent with Liver carcinoma | Radiology Consistent with Alpha one fetoprotein measurement | Radiology Consistent with Liver Cirrhosis
Item
patients with histologically confirmed hepatocellular carcinoma (hcc) or a combination of radiologically compatible finding to hcc, alpha-fetoprotein > 400ng/ml and liver cirrhosis
boolean
C2239176 (UMLS CUI [1])
C0043299 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0043299 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0201539 (UMLS CUI [3,3])
C0043299 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0023890 (UMLS CUI [4,3])
Disease Inoperable | Disease Extrahepatic | Main portal vein Involvement | Main portal vein Invasion | Main portal vein Tumor Thrombus | Hepatic vein Involvement | Hepatic vein Invasion | Hepatic vein Tumor Thrombus | Liver carcinoma Inappropriate Therapeutic procedure Intraarterial | Liver carcinoma Inappropriate Ablation
Item
inoperable disease as defined by (localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin or presence of extra-hepatic disease or main portal vein or hepatic vein involvement (invasion or tumor thrombus) or the hcc must not be amenable to intra-arterial therapy or local ablative therapy)
boolean
C0012634 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C1183135 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C1183135 (UMLS CUI [4,1])
C1269955 (UMLS CUI [4,2])
C1183135 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C0087086 (UMLS CUI [5,3])
C0019155 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0019155 (UMLS CUI [7,1])
C1269955 (UMLS CUI [7,2])
C0019155 (UMLS CUI [8,1])
C0027651 (UMLS CUI [8,2])
C0087086 (UMLS CUI [8,3])
C2239176 (UMLS CUI [9,1])
C1548788 (UMLS CUI [9,2])
C0087111 (UMLS CUI [9,3])
C0694634 (UMLS CUI [9,4])
C2239176 (UMLS CUI [10,1])
C1548788 (UMLS CUI [10,2])
C0547070 (UMLS CUI [10,3])
Life Expectancy
Item
minimum life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Albumin measurement | Prothrombin time international normalized ratio (PT-INR) | Activated Partial Thromboplastin Time measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
(hemoglobin > 9.0 g/dl,absolute neutrophil count>1,500/mm3, platelet count>75,000/μl,total bilirubin < 1.5 times the upper limit of normal,alt and ast < 5 x upper limit of normal,albumin ≥ 3g/dl,pt-inr/ptt < 1.5 x upper limit of normal,serum creatinine < 1.5 x upper limit of normal or creatinine clearance ≥ 50ml/min)
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201838 (UMLS CUI [7])
C1821762 (UMLS CUI [8])
C0030605 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
C0373595 (UMLS CUI [11])
Informed Consent
Item
signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Fine needle aspiration biopsy
Item
fna will be performed in patients with feasible biopsy site
boolean
C1510483 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis | Child-Pugh Classification
Item
decompensated cirrhosis or stage c (index > 10) according to the child-pugh classification
boolean
C1619727 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
Antineoplastic Agents | Tamoxifen | Interferon
Item
other concomitant anticancer agent, including tamoxifen and interferon
boolean
C0003392 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
Communicable Diseases Serious CTCAE Grades
Item
active clinically serious infections (> grade 2 ctcae version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Organ Allograft
Item
history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Bleeding tendency
Item
patients with evidence or history of bleeding diasthesis
boolean
C1458140 (UMLS CUI [1])
Dialysis
Item
patients undergoing renal dialysis
boolean
C0011946 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiotherapy during study or within 4 weeks of start of study drug.
boolean
C1522449 (UMLS CUI [1])
Exposure to Investigational New Drugs
Item
prior exposure to the study drug.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C3840291 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
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