ID

79

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00661609

Lien

http://clinicaltrials.gov/ct2/show/record/NCT00661609

Mots-clés

Versions (3)
  1. 18/11/2011 18/11/2011 -
  2. 26/03/2014 26/03/2014 - Martin Dugas
  3. 17/09/2021 17/09/2021 -
Téléchargé le

18 novembre 2011

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy
Modèle Commentaires :

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Eligibility NCT00661609 Bladder Cancer

Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra)
Description

Urothelial cancer

Type de données

boolean

Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
Description

Stage IV

Type de données

boolean

Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting
Description

Prior chemotherapy

Type de données

boolean

Ambulatory and capable of all selfcare more than 50% of waking hours
Description

General status

Type de données

boolean

Exclusion criteria
Description

Exclusion criteria

Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication, 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
Description

Prior treatment

Type de données

boolean

Inadequate bone marrow reserve
Description

Bone marrow

Type de données

boolean

Inadequate liver function in the presence of liver metastases
Description

Liver

Type de données

boolean

Impaired renal function
Description

Kidney

Type de données

boolean

Medical concepts
Description

Medical concepts

Diagnosis
Description

Diagnosis

Type de données

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Carcinoma of bladder
Description

Bladder Cancer

Type de données

string

Alias
UMLS CUI
C0699885
SNOMED CT 2010_0731
255108000
MedDRA 13.1
10005014
Diagnostic Neoplasm Staging
Description

Tumor Staging

Type de données

string

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

Chemotherapy

Type de données

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Ambulatory
Description

Ambulatory

Type de données

string

Alias
UMLS CUI
C0439841
Radiotherapy
Description

Radiotherapy

Type de données

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
White Blood Cells
Description

WBC

Type de données

string

Alias
SNOMED CT 2010_0731
767002
LOINC Version 232
6690-2
Platelet count - finding
Description

Platelet count

Type de données

string

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

Hemoglobin

Type de données

string

Alias
UMLS CUI
C0019046
SNOMED CT 2010_0731
38082009
MedDRA 13.1
10019481
LOINC Version 232
LP14449-0
Metastatic Malignant Neoplasm to the Liver
Description

Liver Metastasis

Type de données

string

Alias
UMLS CUI
C0494165
SNOMED CT 2010_0731
94381002
MedDRA 13.1
10027457
ICD-10-CM Version 2010
C78.7
ICD-9-CM Version 2011
197.7
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion criteria
Urothelial cancer
Item
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra)
boolean
Stage IV
Item
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
boolean
Prior chemotherapy
Item
Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting
boolean
General status
Item
Ambulatory and capable of all selfcare more than 50% of waking hours
boolean
Item Group
Exclusion criteria
Prior treatment
Item
Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication, 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
boolean
Bone marrow
Item
Inadequate bone marrow reserve
boolean
Liver
Item
Inadequate liver function in the presence of liver metastases
boolean
Kidney
Item
Impaired renal function
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Bladder Cancer
Item
Carcinoma of bladder
string
C0699885 (UMLS CUI)
255108000 (SNOMED CT 2010_0731)
10005014 (MedDRA 13.1)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Ambulatory
Item
Ambulatory
string
C0439841 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
WBC
Item
White Blood Cells
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Hemoglobin
Item
Hemoglobin
string
C0019046 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Liver Metastasis
Item
Metastatic Malignant Neoplasm to the Liver
string
C0494165 (UMLS CUI)
94381002 (SNOMED CT 2010_0731)
10027457 (MedDRA 13.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
Retour au début de la page 

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