ID

10676

Beskrivning

Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon ODM derived from http://clinicaltrials.gov/show/NCT00226408

Länk

http://clinicaltrials.gov/show/NCT00226408

Nyckelord

Versioner (3)
  1. 2012-02-13 2012-02-13 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
  3. 2015-06-06 2015-06-06 - Martin Dugas
Uppladdad den

6 juni 2015

DOI

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Licens

Creative Commons BY 4.0
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Melanoma Eligibility Interferon Alpha NCT00226408

Tysk Engelsk

Eligibility Melanoma NCT00226408

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
18-17 Jahre
Beskrivning

Age

Datatyp

boolean

Histological documented cutaneous malignant melanoma Stage IIIa, IIIb, IIIc (AJCC 2002)
Beskrivning

Melanoma IIIa,b,c

Datatyp

boolean

R0 resection dating back no longer than 56 days
Beskrivning

R0

Datatyp

boolean

Performance status (ECOG 0-1)
Beskrivning

ECOG 0-1

Datatyp

boolean

Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl
Beskrivning

Bone marrow

Datatyp

boolean

Alias
UMLS CUI-1
C0005953
UMLS CUI-2
C0023508
UMLS CUI-3
C0518015
Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
Beskrivning

Liver and kidney

Datatyp

boolean

Written inform consent
Beskrivning

consent

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Confirmed distant metastasis
Beskrivning

distant metastasis

Datatyp

boolean

Alias
UMLS CUI-1
C0456957
Choroid or mucosal melanoma
Beskrivning

Choroid or mucosal melanoma

Datatyp

boolean

Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
Beskrivning

Pregnancy/lactation

Datatyp

boolean

Active autoimmun disease
Beskrivning

Active autoimmun disease

Datatyp

boolean

patients with history of neuropsychiatric disease requiring hospitalization
Beskrivning

patients with history of neuropsychiatric disease requiring hospitalization

Datatyp

boolean

Severe medical condition such us: Florid hepatitis, Severe acute infection, Myocardial infarction within the past year, symptomatic angina pectoris, Grade III to IV congestive heart failure, serious pulmonary disease, HIV-positive patients with an AIDS - defining condition
Beskrivning

Severe medical conditions

Datatyp

boolean

treatment in another clinical drug trial within the last 30 days
Beskrivning

other trial

Datatyp

boolean

A history of hypersensitivity to interferon alfa
Beskrivning

allergy

Datatyp

boolean

History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
Beskrivning

other cancer

Datatyp

boolean

Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
Beskrivning

prior interferon

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Diagnose
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Malignes Melanom
Beskrivning

Melanoma

Datatyp

string

Alias
UMLS CUI
C0025202
SNOMED CT 2010_0731
2092003
MedDRA 13.1
10025650
Tumor Staging
Beskrivning

Tumor Staging

Datatyp

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Therapeutische Prozedur
Beskrivning

Therapeutic procedure

Datatyp

string

Alias
UMLS CUI
C0087111
ECOG Status
Beskrivning

ECOG

Datatyp

string

Alias
UMLS CUI
C1520224
SNOMED CT 2010_0731
424122007
Leukozyten-Anzahl
Beskrivning

Leukocyte Count

Datatyp

string

Alias
UMLS CUI
C0023508
SNOMED CT 2010_0731
767002
MedDRA 13.1
10047939
Thrombozyten
Beskrivning

Platelet count

Datatyp

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Kreatinin
Beskrivning

Creatinine

Datatyp

string

Alias
UMLS CUI
C0201976
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
AST
Beskrivning

AST

Datatyp

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
MedDRA 13.1
10003543
ALT
Beskrivning

ALT

Datatyp

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
MedDRA 13.1
10001844
Bilirubin
Beskrivning

Bilirubin

Datatyp

string

Alias
UMLS CUI
C1278039
SNOMED CT 2010_0731
79706000
LOINC Version 232
1975-2
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Metastasierung
Beskrivning

Metastasis

Datatyp

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
schwanger
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillzeit
Beskrivning

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Kontrazeption
Beskrivning

Contraception

Datatyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Autoimmunerkrankung
Beskrivning

Autoimmune Disorder

Datatyp

string

Alias
UMLS CUI
C0004364
SNOMED CT 2010_0731
85828009
MedDRA 13.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE Version 4.03
E11258
Psychose
Beskrivning

Psychotic Disorders

Datatyp

string

Alias
UMLS CUI
C0033975
SNOMED CT 2010_0731
69322001
MedDRA 13.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE Version 4.03
E12954
Hepatitis
Beskrivning

Hepatitis

Datatyp

string

Alias
UMLS CUI
C0019158
SNOMED CT 2010_0731
29001004
MedDRA 13.1
10019717
Sepsis
Beskrivning

Sepsis

Datatyp

string

Alias
UMLS CUI
C0243026
SNOMED CT 2010_0731
91302008
MedDRA 13.1
10040047
ICD-9-CM Version 2011
995.91
Herzinfarkt
Beskrivning

Myocardial Infarction (MI)

Datatyp

string

Alias
UMLS CUI
C0027051
SNOMED CT 2010_0731
22298006
MedDRA 13.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE Version 4.03
E10152
Herzinsuffizienz
Beskrivning

Chronic congestive heart failure

Datatyp

string

Alias
UMLS CUI
C0264722
SNOMED CT 2010_0731
42343007
MedDRA 13.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50
ICD-9-CM Version 2011
428
Lungenerkrankung
Beskrivning

Pulmonary disease

Datatyp

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
AIDS
Beskrivning

AIDS

Datatyp

string

Alias
UMLS CUI
C0001175
SNOMED CT 2010_0731
62479008
MedDRA 13.1
10000565
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Registrierung
Beskrivning

Enrollment

Datatyp

string

Alias
UMLS CUI
C2348568
Allergie
Beskrivning

Allergy

Datatyp

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Krebs
Beskrivning

Cancer

Datatyp

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Medikation
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI
C0013227
Tillbaka till toppen

Similar models

Eligibility Melanoma NCT00226408

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
Age
Item
18-17 Jahre
boolean
Melanoma IIIa,b,c
Item
Histological documented cutaneous malignant melanoma Stage IIIa, IIIb, IIIc (AJCC 2002)
boolean
R0
Item
R0 resection dating back no longer than 56 days
boolean
ECOG 0-1
Item
Performance status (ECOG 0-1)
boolean
Bone marrow
Item
Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl
boolean
C0005953 (UMLS CUI-1)
C0023508 (UMLS CUI-2)
C0518015 (UMLS CUI-3)
Liver and kidney
Item
Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
boolean
consent
Item
Written inform consent
boolean
Item Group
Ausschlusskriterien
distant metastasis
Item
Confirmed distant metastasis
boolean
C0456957 (UMLS CUI-1)
Choroid or mucosal melanoma
Item
Choroid or mucosal melanoma
boolean
Pregnancy/lactation
Item
Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
boolean
Active autoimmun disease
Item
Active autoimmun disease
boolean
patients with history of neuropsychiatric disease requiring hospitalization
Item
patients with history of neuropsychiatric disease requiring hospitalization
boolean
Severe medical conditions
Item
Severe medical condition such us: Florid hepatitis, Severe acute infection, Myocardial infarction within the past year, symptomatic angina pectoris, Grade III to IV congestive heart failure, serious pulmonary disease, HIV-positive patients with an AIDS - defining condition
boolean
other trial
Item
treatment in another clinical drug trial within the last 30 days
boolean
allergy
Item
A history of hypersensitivity to interferon alfa
boolean
other cancer
Item
History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
boolean
prior interferon
Item
Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
boolean
Item Group
Medizinische Konzepte
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignes Melanom
string
C0025202 (UMLS CUI)
2092003 (SNOMED CT 2010_0731)
10025650 (MedDRA 13.1)
Tumor Staging
Item
Tumor Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutische Prozedur
string
C0087111 (UMLS CUI)
ECOG
Item
ECOG Status
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Leukocyte Count
Item
Leukozyten-Anzahl
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
10047939 (MedDRA 13.1)
Platelet count
Item
Thrombozyten
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Creatinine
Item
Kreatinin
string
C0201976 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
AST
Item
AST
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
ALT
Item
ALT
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
Bilirubin
Item
Bilirubin
string
C1278039 (UMLS CUI)
79706000 (SNOMED CT 2010_0731)
1975-2 (LOINC Version 232)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Metastasis
Item
Metastasierung
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Autoimmune Disorder
Item
Autoimmunerkrankung
string
C0004364 (UMLS CUI)
85828009 (SNOMED CT 2010_0731)
10061664 (MedDRA 13.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE Version 4.03)
Psychotic Disorders
Item
Psychose
string
C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
Hepatitis
Item
Hepatitis
string
C0019158 (UMLS CUI)
29001004 (SNOMED CT 2010_0731)
10019717 (MedDRA 13.1)
Sepsis
Item
Sepsis
string
C0243026 (UMLS CUI)
91302008 (SNOMED CT 2010_0731)
10040047 (MedDRA 13.1)
995.91 (ICD-9-CM Version 2011)
Myocardial Infarction (MI)
Item
Herzinfarkt
string
C0027051 (UMLS CUI)
22298006 (SNOMED CT 2010_0731)
10028596 (MedDRA 13.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE Version 4.03)
Chronic congestive heart failure
Item
Herzinsuffizienz
string
C0264722 (UMLS CUI)
42343007 (SNOMED CT 2010_0731)
10007559 (MedDRA 13.1)
MTHU020787 (LOINC Version 232)
I50 (ICD-10-CM Version 2010)
428 (ICD-9-CM Version 2011)
Pulmonary disease
Item
Lungenerkrankung
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
AIDS
Item
AIDS
string
C0001175 (UMLS CUI)
62479008 (SNOMED CT 2010_0731)
10000565 (MedDRA 13.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Enrollment
Item
Registrierung
string
C2348568 (UMLS CUI)
Allergy
Item
Allergie
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI)
Tillbaka till toppen 

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