ID

44103

Beschreibung

The Role of Low Molecular Weight Heparins (LMWH) Combined With Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00827554

Link

https://clinicaltrials.gov/show/NCT00827554

Stichworte

Versionen (2)
  1. 20.04.18 20.04.18 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00827554

Englisch

Eligibility Hepatocellular Carcinoma NCT00827554

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adults patients with a diagnosis of hcc which is not amenable to surgical resection, liver transplantation or local ablative therapy
Beschreibung

Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Transplantation of liver | Liver carcinoma Inappropriate Local ablative therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0023911
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0547070
2. without metastasis out of liver
Beschreibung

Absence Neoplasm Metastasis Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C1517058
3. patients must have at least one tumor lesion that meets both of the following criteria:
Beschreibung

Neoplasm Lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1265611
1. the lesion can be accurately measured in at least one dimension according to recist criteria
Beschreibung

Measurable lesion Dimensions Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C1265611
2. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
Beschreibung

Absence Operative Surgical Procedures Lesion | Absence Therapeutic radiology procedure Lesion | Absence Radiofrequency ablation Lesion | Absence Percutaneous ethanol injection therapy Lesion | Absence Acetic Acid Injection Lesion | Absence Cryosurgery Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0221198
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0221198
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0850292
UMLS CUI [3,3]
C0221198
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1535909
UMLS CUI [4,3]
C0221198
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0000983
UMLS CUI [5,3]
C1828121
UMLS CUI [5,4]
C0221198
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0010408
UMLS CUI [6,3]
C0221198
4. ecog performance status (ps) <2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy
Beschreibung

Absence Antiangiogenic therapy Targeted | Metronomic Chemotherapy allowed | Systemic Chemotherapy Discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2363719
UMLS CUI [1,3]
C1521840
UMLS CUI [2,1]
C1881814
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C1883256
UMLS CUI [3,2]
C1444662
6. child-pugh class a or b
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
7. no significant renal impairment (creatinine clearance < 30 ml/minute) or patients on dialysis
Beschreibung

Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0011946
8. ability to understand the protocol and to agree to and sign a written informed consent document -
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hbsag(-)，afp(-).
Beschreibung

Hepatitis B Surface Antigens Negative | alpha-Fetoproteins Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0002210
UMLS CUI [2,2]
C1513916
2. prothrombin time prolonged more than 4s.
Beschreibung

Prothrombin time increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151872
3. blood platelets count less than 50000/l.
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
4. renal failure requiring dialysis.
Beschreibung

Kidney Failure Requirement Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
5. child-pugh class c hepatic impairment.
Beschreibung

Hepatic impairment Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C4050412
6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Beschreibung

Gastrointestinal Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0017181
7. history of organ allograft.
Beschreibung

Organ Allograft

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
8. substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0038586
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
9. known or suspected allergy to the investigational agents or any agent given in association with this trial.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
10. pregnant or breast-feeding patients.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT00827554

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Transplantation of liver | Liver carcinoma Inappropriate Local ablative therapy
Item
1. adults patients with a diagnosis of hcc which is not amenable to surgical resection, liver transplantation or local ablative therapy
boolean
C2239176 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0547070 (UMLS CUI [3,3])
Absence Neoplasm Metastasis Extrahepatic
Item
2. without metastasis out of liver
boolean
C0332197 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Neoplasm Lesion Quantity
Item
3. patients must have at least one tumor lesion that meets both of the following criteria:
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Measurable lesion Dimensions Quantity
Item
1. the lesion can be accurately measured in at least one dimension according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Absence Operative Surgical Procedures Lesion | Absence Therapeutic radiology procedure Lesion | Absence Radiofrequency ablation Lesion | Absence Percutaneous ethanol injection therapy Lesion | Absence Acetic Acid Injection Lesion | Absence Cryosurgery Lesion
Item
2. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
boolean
C0332197 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0850292 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C1535909 (UMLS CUI [4,2])
C0221198 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0000983 (UMLS CUI [5,2])
C1828121 (UMLS CUI [5,3])
C0221198 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C0010408 (UMLS CUI [6,2])
C0221198 (UMLS CUI [6,3])
ECOG performance status
Item
4. ecog performance status (ps) <2
boolean
C1520224 (UMLS CUI [1])
Absence Antiangiogenic therapy Targeted | Metronomic Chemotherapy allowed | Systemic Chemotherapy Discontinued
Item
5. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy
boolean
C0332197 (UMLS CUI [1,1])
C2363719 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1881814 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C1883256 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Child-Pugh Classification
Item
6. child-pugh class a or b
boolean
C4050412 (UMLS CUI [1])
Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis
Item
7. no significant renal impairment (creatinine clearance < 30 ml/minute) or patients on dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Comprehension Study Protocol | Informed Consent
Item
8. ability to understand the protocol and to agree to and sign a written informed consent document -
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B Surface Antigens Negative | alpha-Fetoproteins Negative
Item
1. hbsag(-)，afp(-).
boolean
C0019168 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0002210 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Prothrombin time increased
Item
2. prothrombin time prolonged more than 4s.
boolean
C0151872 (UMLS CUI [1])
Platelet Count measurement
Item
3. blood platelets count less than 50000/l.
boolean
C0032181 (UMLS CUI [1])
Kidney Failure Requirement Dialysis
Item
4. renal failure requiring dialysis.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Hepatic impairment Child-Pugh Classification
Item
5. child-pugh class c hepatic impairment.
boolean
C0948807 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Gastrointestinal Hemorrhage
Item
6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.
boolean
C0017181 (UMLS CUI [1])
Organ Allograft
Item
7. history of organ allograft.
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders Interfere with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Condition Interferes with Evaluation Research results
Item
8. substance abuse (current), 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])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
9. known or suspected allergy to the investigational agents or any agent given in association with this trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
10. pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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