ID

16912

Beschreibung

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00425672

Link

https://clinicaltrials.gov/show/NCT00425672

Stichworte

Versionen (1)
  1. 13.08.16 13.08.16 -
Hochgeladen am

13. August 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Male Breast Cancer NCT00425672

Englisch

Eligibility Male Breast Cancer NCT00425672

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced stage refractory breast cancer
Beschreibung

Refractory breast cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205269
progressive or relapsed disease following standard therapy
Beschreibung

progressive or relapsed disease following standard therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0087111
patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional ct techniques or >= 10 mm with spiral ct scan; measurable (bi-dimensional) chest wall disease will also be allowed
Beschreibung

Measurable disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
Beschreibung

Cytotoxic chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0677881
white blood cell count (wbc) > 3.0 thou/ul
Beschreibung

White blood cell count

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
anc > 1.0 thou/ul
Beschreibung

Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets >= 100 thou/ul
Beschreibung

Platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
Beschreibung

Serum creatinine or creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
alt/ast =< 2.0 x upper limit of normal
Beschreibung

ALT/AST

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin =< 1.5 x upper limit of normal
Beschreibung

Total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
albumin >= 3.0 g/dl
Beschreibung

Albumin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201838
subjects must have a performance status score (ecog scale) =< 2
Beschreibung

ECOG

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
Beschreibung

Active concurrent medical illness precluding protocol treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
Beschreibung

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with ontak (dab389 il-2) or dab486 il-2
Beschreibung

Prior treatment with ontak (dab389 il-2) or dab486 il-2

Datentyp

boolean

Alias
UMLS CUI [1]
C0722264
UMLS CUI [2]
C0063713
known history of hypersensitivity to diphtheria toxin or il-2
Beschreibung

Hypersensitivity to diphtheria toxin or il-2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012550
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021756
active autoimmune disease
Beschreibung

Autoimmune disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
known history of pulmonary disease except controlled asthma
Beschreibung

Pulmonary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
Beschreibung

cardiovascular disease as defined by new york heart association class iii-iv categorization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
pregnant or breast-feeding women
Beschreibung

Pregnant or breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Male Breast Cancer NCT00425672

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Refractory breast cancer
Item
patients with advanced stage refractory breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
progressive or relapsed disease following standard therapy
Item
progressive or relapsed disease following standard therapy
boolean
C0677932 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Measurable disease
Item
patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional ct techniques or >= 10 mm with spiral ct scan; measurable (bi-dimensional) chest wall disease will also be allowed
boolean
C1513041 (UMLS CUI [1])
Cytotoxic chemotherapy
Item
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
boolean
C0677881 (UMLS CUI [1])
White blood cell count
Item
white blood cell count (wbc) > 3.0 thou/ul
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
anc > 1.0 thou/ul
boolean
C0200633 (UMLS CUI [1])
Platelet count
Item
platelets >= 100 thou/ul
boolean
C0032181 (UMLS CUI [1])
Serum creatinine or creatinine clearance
Item
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
ALT/AST
Item
alt/ast =< 2.0 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Total bilirubin
Item
total bilirubin =< 1.5 x upper limit of normal
boolean
C0201913 (UMLS CUI [1])
Albumin
Item
albumin >= 3.0 g/dl
boolean
C0201838 (UMLS CUI [1])
ECOG
Item
subjects must have a performance status score (ecog scale) =< 2
boolean
C1520224 (UMLS CUI [1])
Active concurrent medical illness precluding protocol treatment
Item
subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
boolean
C0525058 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraceptive methods
Item
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior treatment with ontak (dab389 il-2) or dab486 il-2
Item
prior treatment with ontak (dab389 il-2) or dab486 il-2
boolean
C0722264 (UMLS CUI [1])
C0063713 (UMLS CUI [2])
Hypersensitivity to diphtheria toxin or il-2
Item
known history of hypersensitivity to diphtheria toxin or il-2
boolean
C0020517 (UMLS CUI [1,1])
C0012550 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021756 (UMLS CUI [2,2])
Autoimmune disease
Item
active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Pulmonary disease
Item
known history of pulmonary disease except controlled asthma
boolean
C0024115 (UMLS CUI [1])
cardiovascular disease as defined by new york heart association class iii-iv categorization
Item
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnant or breast-feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video