ID

29812

Beschrijving

Phase II/III Trial of Hepatocellular Carcinoma Patients Treated by ex Vivo Expanded Autologous Immune Killer Cells as the Adjunct Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01024530

Link

https://clinicaltrials.gov/show/NCT01024530

Trefwoorden

Versies (2)
  1. 21-04-18 21-04-18 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01024530

Engels

Eligibility Hepatocellular Carcinoma NCT01024530

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. sign and give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. age≧20 years, but＜80 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. hepatocellular carcinoma by ct, mri, afp, angiography or cytology/biopsy examinations.
Beschrijving

Liver carcinoma CT | Liver carcinoma MRI | Liver carcinoma Alpha one fetoprotein measurement | Liver carcinoma Angiography | Liver carcinoma Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0201539
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0002978
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0005558
4. barcelona staging system stage b and c.
Beschrijving

Hepatocellular Carcinoma by BCLC Stage

Datatype

boolean

Alias
UMLS CUI [1]
C3898888
5. never receive tace treatment and comply with the standard of tace treatment.
Beschrijving

Transarterial Chemoembolization Absent | Compliance behavior TACE Standard therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3539919
UMLS CUI [2,3]
C2936643
6. child-pugh stage a and b.
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
7. ecog performance status 0 to 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participant of other clinical trial within the past 4 weeks of screening period.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
2. receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy | Local Therapy | Targeted Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279025
UMLS CUI [5]
C1517925
UMLS CUI [6]
C2985566
3. carriers of hiv or htlv within the past 4 weeks of screening period.
Beschrijving

HIV carrier | HTLV-1 carrier

Datatype

boolean

Alias
UMLS CUI [1]
C0853961
UMLS CUI [2]
C2747810
4. with active acute or chronic infection（by investigator's judgement）.
Beschrijving

Communicable Disease | Chronic infectious disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
5. other diseases, except hepatocellular carcinoma, which are life-threatening to the patients（by investigator's judgement)for example:
Beschrijving

Life threatening illness | Exception Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
5.1 active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
Beschrijving

Heart Diseases | Coronary Artery Disease Treatment required for | Congestive heart failure | Cardiac Arrhythmia | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0332121
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0027051
5.2 with previous history of encephalopathy within the past six months. 5.3 involved involving systemically or known central nerve system diseases（brain or meningeal metastasis）.
Beschrijving

Encephalopathy | Involvement Systemic | CNS disorder | Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Datatype

boolean

Alias
UMLS CUI [1]
C0085584
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0007682
UMLS CUI [4]
C0220650
UMLS CUI [5]
C1704231
6. women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Hepatocellular Carcinoma NCT01024530

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. sign and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age≧20 years, but＜80 years.
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma CT | Liver carcinoma MRI | Liver carcinoma Alpha one fetoprotein measurement | Liver carcinoma Angiography | Liver carcinoma Biopsy
Item
3. hepatocellular carcinoma by ct, mri, afp, angiography or cytology/biopsy examinations.
boolean
C2239176 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0201539 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Hepatocellular Carcinoma by BCLC Stage
Item
4. barcelona staging system stage b and c.
boolean
C3898888 (UMLS CUI [1])
Transarterial Chemoembolization Absent | Compliance behavior TACE Standard therapy
Item
5. never receive tace treatment and comply with the standard of tace treatment.
boolean
C3539919 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3539919 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Child-Pugh Classification
Item
6. child-pugh stage a and b.
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
1. participant of other clinical trial within the past 4 weeks of screening period.
boolean
C2348568 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy | Local Therapy | Targeted Therapy
Item
2. receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1517925 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
HIV carrier | HTLV-1 carrier
Item
3. carriers of hiv or htlv within the past 4 weeks of screening period.
boolean
C0853961 (UMLS CUI [1])
C2747810 (UMLS CUI [2])
Communicable Disease | Chronic infectious disease
Item
4. with active acute or chronic infection（by investigator's judgement）.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Life threatening illness | Exception Liver carcinoma
Item
5. other diseases, except hepatocellular carcinoma, which are life-threatening to the patients（by investigator's judgement)for example:
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Heart Diseases | Coronary Artery Disease Treatment required for | Congestive heart failure | Cardiac Arrhythmia | Myocardial Infarction
Item
5.1 active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
boolean
C0018799 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Encephalopathy | Involvement Systemic | CNS disorder | Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
5.2 with previous history of encephalopathy within the past six months. 5.3 involved involving systemically or known central nerve system diseases（brain or meningeal metastasis）.
boolean
C0085584 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C1704231 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
6. women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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