ID

36072

Beskrivning

A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02460991

Länk

https://clinicaltrials.gov/show/NCT02460991

Nyckelord

Versioner (1)
  1. 2019-04-13 2019-04-13 -
Rättsinnehavare

See clinicaltrials.gov

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13 april 2019

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02460991

Engelsk

Eligibility Hepatocellular Carcinoma NCT02460991

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. ≥18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. diagnosis of hcc
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
4. locally advanced hcc
Beskrivning

Liver carcinoma Advanced Locally

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
5. preserved liver function
Beskrivning

Liver function Preserved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0033085
6. eastern cooperative oncology group 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of extra-hepatic spread of disease.
Beskrivning

Disease Spread Extrahepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C1517058
2. macrovascular invasion of lobar portal vein branches or main portal vein.
Beskrivning

Tumor Vascular Invasion Branch of portal vein | Tumor Vascular Invasion Main portal vein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521157
UMLS CUI [1,2]
C0226736
UMLS CUI [2,1]
C0521157
UMLS CUI [2,2]
C1183135
3. candidate for surgical resection, transplantation, or local ablation.
Beskrivning

Patient Eligible Excision | Patient Eligible Transplantation | Patient Eligible Ablation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0040732
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548635
UMLS CUI [3,3]
C0547070
4. prior intra-arterial embolization, chemotherapy or systemic therapy for hcc.
Beskrivning

Intra-arterial Embolization Liver carcinoma | Chemotherapy Liver carcinoma | Systemic therapy Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013931
UMLS CUI [1,2]
C0694634
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C2239176
5. any contraindication for tace.
Beskrivning

Medical contraindication TACE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3539919
6. platelet count <50,000/mm3 or international normalized ratio >1.5.
Beskrivning

Platelet Count measurement | International Normalized Ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0525032
7. previous treatment with anthracycline antibiotics (e.g. doxorubicin) or sorafenib.
Beskrivning

Anthracycline Antibiotics | Doxorubicin | sorafenib

Datatyp

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2]
C0013089
UMLS CUI [3]
C1516119
8. unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
Beskrivning

Coronary Artery Disease Unstable | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0027051
9. known ejection fraction < 50%.
Beskrivning

Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
10. current infections requiring antibiotic therapy.
Beskrivning

Communicable Diseases Requirement Antibiotic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
11. suffering from a known bleeding disorder.
Beskrivning

Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
12. renal insufficiency (serum creatinine > 2 mg/dl).
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
13. aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
14. presence of advanced liver disease.
Beskrivning

Liver disease Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
15. any contraindication for doxorubicin administration:
Beskrivning

Medical contraindication Doxorubicin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013089
16. any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
Beskrivning

Comorbidity Protocol Compliance Poor | Social situation Protocol Compliance Poor | Comorbidity compromises Patient safety | Social situation compromises Patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0542537
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0542537
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C1113679
17. patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
Beskrivning

Second Primary Cancer | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Malignant melanoma in situ | Exception Prostate carcinoma Treated | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1336527
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0854696
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
18. participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
Beskrivning

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
19. pregnant or breast-feeding patients.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatocellular Carcinoma NCT02460991

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma
Item
3. diagnosis of hcc
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma Advanced Locally
Item
4. locally advanced hcc
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
Liver function Preserved
Item
5. preserved liver function
boolean
C0232741 (UMLS CUI [1,1])
C0033085 (UMLS CUI [1,2])
ECOG performance status
Item
6. eastern cooperative oncology group 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Spread Extrahepatic
Item
1. presence of extra-hepatic spread of disease.
boolean
C0012634 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Tumor Vascular Invasion Branch of portal vein | Tumor Vascular Invasion Main portal vein
Item
2. macrovascular invasion of lobar portal vein branches or main portal vein.
boolean
C0521157 (UMLS CUI [1,1])
C0226736 (UMLS CUI [1,2])
C0521157 (UMLS CUI [2,1])
C1183135 (UMLS CUI [2,2])
Patient Eligible Excision | Patient Eligible Transplantation | Patient Eligible Ablation
Item
3. candidate for surgical resection, transplantation, or local ablation.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548635 (UMLS CUI [3,2])
C0547070 (UMLS CUI [3,3])
Intra-arterial Embolization Liver carcinoma | Chemotherapy Liver carcinoma | Systemic therapy Liver carcinoma
Item
4. prior intra-arterial embolization, chemotherapy or systemic therapy for hcc.
boolean
C0013931 (UMLS CUI [1,1])
C0694634 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
Medical contraindication TACE
Item
5. any contraindication for tace.
boolean
C1301624 (UMLS CUI [1,1])
C3539919 (UMLS CUI [1,2])
Platelet Count measurement | International Normalized Ratio
Item
6. platelet count <50,000/mm3 or international normalized ratio >1.5.
boolean
C0032181 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Anthracycline Antibiotics | Doxorubicin | sorafenib
Item
7. previous treatment with anthracycline antibiotics (e.g. doxorubicin) or sorafenib.
boolean
C0003234 (UMLS CUI [1])
C0013089 (UMLS CUI [2])
C1516119 (UMLS CUI [3])
Coronary Artery Disease Unstable | Myocardial Infarction
Item
8. unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
boolean
C1956346 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Cardiac ejection fraction
Item
9. known ejection fraction < 50%.
boolean
C0232174 (UMLS CUI [1])
Communicable Diseases Requirement Antibiotic therapy
Item
10. current infections requiring antibiotic therapy.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
11. suffering from a known bleeding disorder.
boolean
C0005779 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
12. renal insufficiency (serum creatinine > 2 mg/dl).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
13. aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Liver disease Advanced
Item
14. presence of advanced liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Medical contraindication Doxorubicin
Item
15. any contraindication for doxorubicin administration:
boolean
C1301624 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
Comorbidity Protocol Compliance Poor | Social situation Protocol Compliance Poor | Comorbidity compromises Patient safety | Social situation compromises Patient safety
Item
16. any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
boolean
C0009488 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0542537 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
Second Primary Cancer | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Malignant melanoma in situ | Exception Prostate carcinoma Treated | Exception Disease Free of
Item
17. patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1336527 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0854696 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
18. participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
19. pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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