ID

10676

Description

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

Lien

http://clinicaltrials.gov/show/NCT00226408

Mots-clés

Versions (3)
  1. 13/02/2012 13/02/2012 -
  2. 13/04/2014 13/04/2014 - Julian Varghese
  3. 06/06/2015 06/06/2015 - Martin Dugas
Téléchargé le

6 juin 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Melanoma Eligibility Interferon Alpha NCT00226408

Allemand Anglais

Eligibility Melanoma NCT00226408

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
18-17 Jahre
Description

Age

Type de données

boolean

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

Melanoma IIIa,b,c

Type de données

boolean

R0 resection dating back no longer than 56 days
Description

R0

Type de données

boolean

Performance status (ECOG 0-1)
Description

ECOG 0-1

Type de données

boolean

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

Bone marrow

Type de données

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
Description

Liver and kidney

Type de données

boolean

Written inform consent
Description

consent

Type de données

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Confirmed distant metastasis
Description

distant metastasis

Type de données

boolean

Alias
UMLS CUI-1
C0456957
Choroid or mucosal melanoma
Description

Choroid or mucosal melanoma

Type de données

boolean

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

Pregnancy/lactation

Type de données

boolean

Active autoimmun disease
Description

Active autoimmun disease

Type de données

boolean

patients with history of neuropsychiatric disease requiring hospitalization
Description

patients with history of neuropsychiatric disease requiring hospitalization

Type de données

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
Description

Severe medical conditions

Type de données

boolean

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

other trial

Type de données

boolean

A history of hypersensitivity to interferon alfa
Description

allergy

Type de données

boolean

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

other cancer

Type de données

boolean

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

prior interferon

Type de données

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Diagnose
Description

Diagnosis

Type de données

string

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

Melanoma

Type de données

string

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

Tumor Staging

Type de données

string

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

Therapeutic procedure

Type de données

string

Alias
UMLS CUI
C0087111
ECOG Status
Description

ECOG

Type de données

string

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

Leukocyte Count

Type de données

string

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

Platelet count

Type de données

string

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

Creatinine

Type de données

string

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

AST

Type de données

string

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

ALT

Type de données

string

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

Bilirubin

Type de données

string

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

Informed Consent

Type de données

string

Alias
UMLS CUI
C0021430
Metastasierung
Description

Metastasis

Type de données

string

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

pregnant

Type de données

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillzeit
Description

Lactation

Type de données

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Kontrazeption
Description

Contraception

Type de données

string

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

Autoimmune Disorder

Type de données

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
Description

Psychotic Disorders

Type de données

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
Description

Hepatitis

Type de données

string

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

Sepsis

Type de données

string

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

Myocardial Infarction (MI)

Type de données

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
Description

Chronic congestive heart failure

Type de données

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
Description

Pulmonary disease

Type de données

string

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

AIDS

Type de données

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
Description

Enrollment

Type de données

string

Alias
UMLS CUI
C2348568
Allergie
Description

Allergy

Type de données

string

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

Cancer

Type de données

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
Description

Pharmaceutical Preparations

Type de données

string

Alias
UMLS CUI
C0013227
Retour au début de la page

Similar models

Eligibility Melanoma NCT00226408

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Retour au début de la page 

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