ID

39760

Beskrivning

Carbon Ion Radiotherapy for Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01167374

Länk

https://clinicaltrials.gov/show/NCT01167374

Nyckelord

Versioner (1)
  1. 2020-02-17 2020-02-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01167374

Engelsk

Eligibility Hepatocellular Carcinoma NCT01167374

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed hcc or diagnosis of hcc according to aasld-guidelines
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
macroscopic tumor
Beskrivning

Tumor macroscopic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0439806
liver-confined disease without extrahepatic disease as diagnosed by ct, mrt, ultrasound and bone scan
Beskrivning

Liver disease CT | Liver disease MRI | Liver disease Ultrasonography | Liver disease Bone scan | Disease Extrahepatic Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0203668
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1517058
UMLS CUI [5,3]
C0332197
minimal distance of tumor edge to the intestines of 1cm
Beskrivning

Distance Tumor Intestines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012751
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0021853
age ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance score ³60
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
for women with childbearing potential, (and men) adequate contraception.
Beskrivning

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
ability of subject to understand character and individual consequences of the clinical trial
Beskrivning

Comprehension Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
written informed consent (must be available before enrolment in the trial)
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
refusal of the patients to take part in the study
Beskrivning

Study Subject Participation Status | Refusal to Participate

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1136454
previous radiotherapy of the hepatobiliary system
Beskrivning

Prior radiation therapy Hepatobiliary System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1711359
margin of < 1cm between tumor edge and intestines
Beskrivning

Margin Tumor Intestines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205284
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0021853
patients who have not yet recovered from acute toxicities of prior therapies
Beskrivning

Toxicity Due to Prior Therapy | Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
known carcinoma < 2 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
Beskrivning

Carcinoma Duration Treatment required for | Interference Investigational Therapy | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0949266
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another clinical study or observation period of competing trials, respectively
Beskrivning

Study Subject Participation Status | Clinical Trial Observation Period

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0302523
UMLS CUI [2,3]
C1948053
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Similar models

Eligibility Hepatocellular Carcinoma NCT01167374

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
histologically confirmed hcc or diagnosis of hcc according to aasld-guidelines
boolean
C2239176 (UMLS CUI [1])
Tumor macroscopic
Item
macroscopic tumor
boolean
C0027651 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Liver disease CT | Liver disease MRI | Liver disease Ultrasonography | Liver disease Bone scan | Disease Extrahepatic Absent
Item
liver-confined disease without extrahepatic disease as diagnosed by ct, mrt, ultrasound and bone scan
boolean
C0023895 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0203668 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Distance Tumor Intestines
Item
minimal distance of tumor edge to the intestines of 1cm
boolean
C0012751 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0021853 (UMLS CUI [1,3])
Age
Item
age ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance score ³60
boolean
C0206065 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
for women with childbearing potential, (and men) adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Comprehension Study Protocol
Item
ability of subject to understand character and individual consequences of the clinical trial
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent (must be available before enrolment in the trial)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Refusal to Participate
Item
refusal of the patients to take part in the study
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2])
Prior radiation therapy Hepatobiliary System
Item
previous radiotherapy of the hepatobiliary system
boolean
C0279134 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
Margin Tumor Intestines
Item
margin of < 1cm between tumor edge and intestines
boolean
C0205284 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0021853 (UMLS CUI [1,3])
Toxicity Due to Prior Therapy | Recovery Lacking
Item
patients who have not yet recovered from acute toxicities of prior therapies
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Carcinoma Duration Treatment required for | Interference Investigational Therapy | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
known carcinoma < 2 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
boolean
C0007097 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0521102 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial Observation Period
Item
participation in another clinical study or observation period of competing trials, respectively
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0302523 (UMLS CUI [2,2])
C1948053 (UMLS CUI [2,3])
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