ID

15233

Beschrijving

Pilot Study of Percutaneous Irreversible Electroporation to Treat Unresectable Hepatic Carcinoma Close to the Gallbladder; ODM derived from: https://clinicaltrials.gov/show/NCT02332551

Link

https://clinicaltrials.gov/show/NCT02332551

Trefwoorden

  1. 23-05-16 23-05-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

23 mei 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatic Carcinoma NCT02332551

Eligibility Hepatic Carcinoma NCT02332551

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
Beschrijving

Liver carcinoma | Biopsy Positive | criteria Non-invasive

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C0205303
tumor from gallbladder is <0.5 cm
Beschrijving

gallbladder neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0016978
not suitable for surgical resection or transplantation,
Beschrijving

Operative Surgical Procedures Inappropriate | Transplantation Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1548788
have at least one, but less than or equal to 3 tumors,
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C1301886
child-pugh class a,b
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
eastern cooperative oncology group (ecog) score of 0-1,
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
american society of anaesthesiologists (asa) score ≤ 3,
Beschrijving

American Society of Anesthesiologists physical status classification

Datatype

boolean

Alias
UMLS CUI [1]
C0450990
a prothrombin time ratio > 50%,
Beschrijving

Prothrombin time ratio

Datatype

boolean

Alias
UMLS CUI [1]
C0483455
platelet count > 80x109/l,
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure,
Beschrijving

Anticoagulant therapy Ability Treatment Termination | Antiplatelet therapy Ability Treatment Termination | Irreversible electroporation system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0871548
UMLS CUI [2,1]
C1096021
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C0871548
UMLS CUI [3]
C3876171
are able to comprehend and willing to sign the written informed consent form (icf),
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
have a life expectancy of at least 3 months.
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligible for surgical treatment or transplantation for hcc,
Beschrijving

Liver carcinoma Operative Surgical Procedures eligible | Liver carcinoma Transplantation eligible

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0040732
UMLS CUI [2,3]
C1548635
hepatic carcinoma developed on an already transplanted liver,
Beschrijving

Liver carcinoma Transplanted liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1280833
cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
Beschrijving

Heart failure | Coronary Artery Disease Continuous | Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0549178
UMLS CUI [3]
C0003811
any active implanted device (eg pacemaker),
Beschrijving

Implants | Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
Beschrijving

Pregnancy Contraceptive methods Absent | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.
Beschrijving

Therapeutic procedure Investigational New Drugs | Therapeutic procedure Irreversible electroporation system | Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3876171
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801

Similar models

Eligibility Hepatic Carcinoma NCT02332551

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Biopsy Positive | criteria Non-invasive
Item
hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
boolean
C2239176 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C0205303 (UMLS CUI [3,2])
gallbladder neoplasm
Item
tumor from gallbladder is <0.5 cm
boolean
C0016978 (UMLS CUI [1])
Operative Surgical Procedures Inappropriate | Transplantation Inappropriate
Item
not suitable for surgical resection or transplantation,
boolean
C0543467 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0040732 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Malignant Neoplasms
Item
have at least one, but less than or equal to 3 tumors,
boolean
C0006826 (UMLS CUI [1])
ID.5
Item
of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
boolean
C0006826 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Child-Pugh Classification
Item
child-pugh class a,b
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0-1,
boolean
C1520224 (UMLS CUI [1])
American Society of Anesthesiologists physical status classification
Item
american society of anaesthesiologists (asa) score ≤ 3,
boolean
C0450990 (UMLS CUI [1])
Prothrombin time ratio
Item
a prothrombin time ratio > 50%,
boolean
C0483455 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 80x109/l,
boolean
C0032181 (UMLS CUI [1])
Anticoagulant therapy Ability Treatment Termination | Antiplatelet therapy Ability Treatment Termination | Irreversible electroporation system
Item
ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure,
boolean
C0150457 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0871548 (UMLS CUI [1,3])
C1096021 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0871548 (UMLS CUI [2,3])
C3876171 (UMLS CUI [3])
Informed consent
Item
are able to comprehend and willing to sign the written informed consent form (icf),
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
have a life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma Operative Surgical Procedures eligible | Liver carcinoma Transplantation eligible
Item
eligible for surgical treatment or transplantation for hcc,
boolean
C2239176 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
Liver carcinoma Transplanted liver
Item
hepatic carcinoma developed on an already transplanted liver,
boolean
C2239176 (UMLS CUI [1,1])
C1280833 (UMLS CUI [1,2])
Heart failure | Coronary Artery Disease Continuous | Cardiac Arrhythmia
Item
cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
boolean
C0018801 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
Implants | Artificial cardiac pacemaker
Item
any active implanted device (eg pacemaker),
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Pregnancy Contraceptive methods Absent | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Therapeutic procedure Investigational New Drugs | Therapeutic procedure Irreversible electroporation system | Compliance behavior Limited
Item
have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C3876171 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial