ID

10676

Descripción

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

Link

http://clinicaltrials.gov/show/NCT00226408

Palabras clave

Versiones (3)
  1. 13/2/12 13/2/12 -
  2. 13/4/14 13/4/14 - Julian Varghese
  3. 6/6/15 6/6/15 - Martin Dugas
Subido en

6 de junio de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Melanoma Eligibility Interferon Alpha NCT00226408

Alemán Inglés

Eligibility Melanoma NCT00226408

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
18 Years to 70 Years
Descripción

18 Years to 70 Years

Tipo de datos

boolean

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

Melanoma IIIa,b,c

Tipo de datos

boolean

R0 resection dating back no longer than 56 days
Descripción

R0

Tipo de datos

boolean

Performance status (ECOG 0-1)
Descripción

ECOG 0-1

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Liver and kidney

Tipo de datos

boolean

Written inform consent
Descripción

consent

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Confirmed distant metastasis
Descripción

Confirmed distant metastasis

Tipo de datos

boolean

Alias
UMLS CUI-1
C0456957
Choroid or mucosal melanoma
Descripción

Choroid or mucosal melanoma

Tipo de datos

boolean

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

Pregnancy/lactation

Tipo de datos

boolean

Active autoimmun disease
Descripción

Active autoimmun disease

Tipo de datos

boolean

patients with history of neuropsychiatric disease requiring hospitalization
Descripción

patients with history of neuropsychiatric disease requiring hospitalization

Tipo de datos

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
Descripción

Severe medical conditions

Tipo de datos

boolean

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

other trial

Tipo de datos

boolean

A history of hypersensitivity to interferon alfa
Descripción

allergy

Tipo de datos

boolean

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

other cancer

Tipo de datos

boolean

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

prior interferon

Tipo de datos

boolean

Medical concepts
Descripción

Medical concepts

Diagnosis
Descripción

Diagnosis

Tipo de datos

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Malignant melanoma
Descripción

Melanoma

Tipo de datos

string

Alias
UMLS CUI
C0025202
SNOMED CT 2010_0731
2092003
MedDRA 13.1
10025650
Diagnostic Neoplasm Staging
Descripción

Tumor Staging

Tipo de datos

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Therapeutic procedure
Descripción

Therapeutic procedure

Tipo de datos

string

Alias
UMLS CUI
C0087111
ECOG performance status finding
Descripción

ECOG

Tipo de datos

string

Alias
UMLS CUI
C1520224
SNOMED CT 2010_0731
424122007
White Blood Cell Count procedure (WBC)
Descripción

Leukocyte Count

Tipo de datos

string

Alias
UMLS CUI
C0023508
SNOMED CT 2010_0731
767002
MedDRA 13.1
10047939
Platelet count - finding
Descripción

Platelet count

Tipo de datos

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Creatinine
Descripción

Creatinine

Tipo de datos

string

Alias
UMLS CUI
C0201976
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
GOT (Serum)
Descripción

AST

Tipo de datos

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
MedDRA 13.1
10003543
GPT (Serum)
Descripción

ALT

Tipo de datos

string

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

Bilirubin

Tipo de datos

string

Alias
UMLS CUI
C1278039
SNOMED CT 2010_0731
79706000
LOINC Version 232
1975-2
Informed Consent
Descripción

Informed Consent

Tipo de datos

string

Alias
UMLS CUI
C0021430
Metastasis
Descripción

Metastasis

Tipo de datos

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
pregnant
Descripción

pregnant

Tipo de datos

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Descripción

Lactation

Tipo de datos

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Descripción

Contraception

Tipo de datos

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Autoimmune Disease
Descripción

Autoimmune Disorder

Tipo de datos

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
Psychosis (Psychotic disorder)
Descripción

Psychotic Disorders

Tipo de datos

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
Descripción

Hepatitis

Tipo de datos

string

Alias
UMLS CUI
C0019158
SNOMED CT 2010_0731
29001004
MedDRA 13.1
10019717
Systemic infection
Descripción

Sepsis

Tipo de datos

string

Alias
UMLS CUI
C0243026
SNOMED CT 2010_0731
91302008
MedDRA 13.1
10040047
ICD-9-CM Version 2011
995.91
Heart infarction
Descripción

Myocardial Infarction (MI)

Tipo de datos

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
Chronic congestive heart failure
Descripción

Chronic congestive heart failure

Tipo de datos

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
Lung diseases
Descripción

Pulmonary disease

Tipo de datos

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
Acquired Immunodeficiency Syndrome
Descripción

AIDS

Tipo de datos

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
Enrollment
Descripción

Enrollment

Tipo de datos

string

Alias
UMLS CUI
C2348568
Hypersensitivity
Descripción

Allergy

Tipo de datos

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Malignant Neoplasms
Descripción

Cancer

Tipo de datos

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
Medication
Descripción

Pharmaceutical Preparations

Tipo de datos

string

Alias
UMLS CUI
C0013227
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Similar models

Eligibility Melanoma NCT00226408

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
18 Years to 70 Years
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, platelets > 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
Exclusion Criteria
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
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignant melanoma
string
C0025202 (UMLS CUI)
2092003 (SNOMED CT 2010_0731)
10025650 (MedDRA 13.1)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
ECOG
Item
ECOG performance status finding
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Leukocyte Count
Item
White Blood Cell Count procedure (WBC)
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
10047939 (MedDRA 13.1)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Creatinine
Item
Creatinine
string
C0201976 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
AST
Item
GOT (Serum)
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
ALT
Item
GPT (Serum)
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
Informed Consent
string
C0021430 (UMLS CUI)
Metastasis
Item
Metastasis
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Autoimmune Disorder
Item
Autoimmune Disease
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
Psychosis (Psychotic disorder)
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
Systemic infection
string
C0243026 (UMLS CUI)
91302008 (SNOMED CT 2010_0731)
10040047 (MedDRA 13.1)
995.91 (ICD-9-CM Version 2011)
Myocardial Infarction (MI)
Item
Heart infarction
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
Chronic congestive heart failure
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
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
AIDS
Item
Acquired Immunodeficiency Syndrome
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
Enrollment
string
C2348568 (UMLS CUI)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Cancer
Item
Malignant Neoplasms
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
Medication
string
C0013227 (UMLS CUI)
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