ID

63

Descrizione

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00050999

collegamento

http://clinicaltrials.gov/ct2/show/record/NCT00050999

Keywords

versioni (3)
  1. 14/11/11 14/11/11 -
  2. 23/03/14 23/03/14 - Martin Dugas
  3. 11/04/14 11/04/14 - Julian Varghese
Caricato su

14 novembre 2011

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility NCT00050999 T-Cell Lymphoma

Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Descrizione

Inclusion

18 Years and older
Descrizione

Age

Tipo di dati

boolean

Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
Descrizione

CTCL

Tipo di dati

boolean

Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
Descrizione

Prior CTCL therapy

Tipo di dati

boolean

Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
Descrizione

Interleukin-2 receptor expression

Tipo di dati

boolean

Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
Descrizione

Disease stage

Tipo di dati

boolean

No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
Descrizione

Other diseases

Tipo di dati

boolean

Willingness to be randomized to a placebo treatment only arm
Descrizione

Willingness placebo

Tipo di dati

boolean

ECOG performance status 0 or 1
Descrizione

ECOG

Tipo di dati

boolean

Exclusion
Descrizione

Exclusion

Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Descrizione

Previous trials

Tipo di dati

boolean

Medical concepts
Descrizione

Medical concepts

Age
Descrizione

Age

Tipo di dati

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Descrizione

Diagnosis

Tipo di dati

string

Alias
UMLS CUI
C0011900
Lymphoma, T-Cell, Cutaneous
Descrizione

CTCL

Tipo di dati

string

Alias
UMLS CUI
C0079773
SNOMED CT 2010_0731
28054005
MedDRA 13.1
10011677
Medication
Descrizione

Pharmaceutical Preparations

Tipo di dati

string

Alias
UMLS CUI
C0013227
Chemotherapy
Descrizione

Chemotherapy

Tipo di dati

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Interleukin 2 Receptor
Descrizione

IL-2R

Tipo di dati

string

Alias
UMLS CUI
C0034819
SNOMED CT 2010_0731
112119008
LOINC Version 232
MTHU011559
Diagnostic Neoplasm Staging
Descrizione

Tumor Staging

Tipo di dati

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Infection
Descrizione

Infection

Tipo di dati

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
CNS disorder
Descrizione

CNS disease

Tipo di dati

string

Alias
UMLS CUI
C0007682
SNOMED CT 2010_0731
23853001
MedDRA 13.1
10007943
ICD-10-CM Version 2010
G96.9
Kidney Diseases
Descrizione

Renal disease

Tipo di dati

string

Alias
UMLS CUI
C0022658
SNOMED CT 2010_0731
90708001
MedDRA 13.1
10029151
ICD-10-CM Version 2010
N18.9
Liver diseases
Descrizione

Liver disorder

Tipo di dati

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Lung diseases
Descrizione

Pulmonary disease

Tipo di dati

string

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

Placebo

Tipo di dati

string

Alias
UMLS CUI
C0032042
ECOG performance status finding
Descrizione

ECOG

Tipo di dati

string

Alias
UMLS CUI
C1828127
SNOMED CT 2010_0731
424122007
Enrollment
Descrizione

Enrollment

Tipo di dati

string

Alias
UMLS CUI
C1516879
Ritorna all'inizio della pagina

Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion
Age
Item
18 Years and older
boolean
CTCL
Item
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
boolean
Prior CTCL therapy
Item
Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
boolean
Interleukin-2 receptor expression
Item
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
boolean
Disease stage
Item
Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
boolean
Other diseases
Item
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
boolean
Willingness placebo
Item
Willingness to be randomized to a placebo treatment only arm
boolean
ECOG
Item
ECOG performance status 0 or 1
boolean
Item Group
Exclusion
Previous trials
Item
Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
CTCL
Item
Lymphoma, T-Cell, Cutaneous
string
C0079773 (UMLS CUI)
28054005 (SNOMED CT 2010_0731)
10011677 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
IL-2R
Item
Interleukin 2 Receptor
string
C0034819 (UMLS CUI)
112119008 (SNOMED CT 2010_0731)
MTHU011559 (LOINC Version 232)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
CNS disease
Item
CNS disorder
string
C0007682 (UMLS CUI)
23853001 (SNOMED CT 2010_0731)
10007943 (MedDRA 13.1)
G96.9 (ICD-10-CM Version 2010)
Renal disease
Item
Kidney Diseases
string
C0022658 (UMLS CUI)
90708001 (SNOMED CT 2010_0731)
10029151 (MedDRA 13.1)
N18.9 (ICD-10-CM Version 2010)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (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)
Placebo
Item
Placebos
string
C0032042 (UMLS CUI)
ECOG
Item
ECOG performance status finding
string
C1828127 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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