ID

37751

Beschreibung

Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00816244

Link

https://clinicaltrials.gov/show/NCT00816244

Stichworte

Versionen (1)
  1. 21.08.19 21.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. August 2019

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 Breast Cancer NCT00816244

Englisch

Eligibility Breast Cancer NCT00816244

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with primary breast cancer who are candidates for radical surgery.
Beschreibung

Gender | Breast Carcinoma Appropriate Surgery Radical

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0543467
UMLS CUI [2,4]
C0439807
breast tumours clinically ≥ 15 mm, nx, m0.
Beschreibung

Breast Carcinoma Size TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0474926
breast tumours identified on mammography and verified on fine needle aspiration.
Beschreibung

Breast Carcinoma Mammography | Breast Carcinoma Fine needle aspiration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0024671
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1510483
age > 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status of ecog ≤ 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
laboratory requirements at the day of diagnosis (t1-):prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
Beschreibung

Renal function Estimated Blood specimen | Creatinine measurement, serum | Liver function Estimated Blood specimen | Transaminase Assay

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0750572
UMLS CUI [1,3]
C0178913
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0750572
UMLS CUI [3,3]
C0178913
UMLS CUI [4]
C0919834
prior to patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
negative pregnancy test for pre menopausal women before inclusion in the trial
Beschreibung

Premenopausal state Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
Beschreibung

Anticholesteremic Agents | Statins | Fibrates | ezetimibe

Datentyp

boolean

Alias
UMLS CUI [1]
C0003277
UMLS CUI [2]
C0360714
UMLS CUI [3]
C1449704
UMLS CUI [4]
C1142985
prior breast cancer treatment.
Beschreibung

Prior Therapy Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
current hrt.
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
known liver disease.
Beschreibung

Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
history of hemorrhagic stroke.
Beschreibung

Brain hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0553692
psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
Beschreibung

Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Condition Familial Interferes with Protocol Compliance | Condition Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0241888
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
UMLS CUI [5,1]
C3850138
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3850138
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0017444
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C3274571
history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
Beschreibung

Allergic Reaction Compound Atorvastatin Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0286651
UMLS CUI [1,4]
C2348205
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00816244

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma Appropriate Surgery Radical
Item
women with primary breast cancer who are candidates for radical surgery.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0439807 (UMLS CUI [2,4])
Breast Carcinoma Size TNM Breast tumor staging
Item
breast tumours clinically ≥ 15 mm, nx, m0.
boolean
C0678222 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Breast Carcinoma Mammography | Breast Carcinoma Fine needle aspiration
Item
breast tumours identified on mammography and verified on fine needle aspiration.
boolean
C0678222 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status of ecog ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Renal function Estimated Blood specimen | Creatinine measurement, serum | Liver function Estimated Blood specimen | Transaminase Assay
Item
laboratory requirements at the day of diagnosis (t1-):prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
boolean
C0232804 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0201976 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0750572 (UMLS CUI [3,2])
C0178913 (UMLS CUI [3,3])
C0919834 (UMLS CUI [4])
Informed Consent
Item
prior to patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
boolean
C0021430 (UMLS CUI [1])
Premenopausal state Pregnancy test negative
Item
negative pregnancy test for pre menopausal women before inclusion in the trial
boolean
C0232969 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Anticholesteremic Agents | Statins | Fibrates | ezetimibe
Item
ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
boolean
C0003277 (UMLS CUI [1])
C0360714 (UMLS CUI [2])
C1449704 (UMLS CUI [3])
C1142985 (UMLS CUI [4])
Prior Therapy Breast Carcinoma
Item
prior breast cancer treatment.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hormone replacement therapy
Item
current hrt.
boolean
C0282402 (UMLS CUI [1])
Liver disease
Item
known liver disease.
boolean
C0023895 (UMLS CUI [1])
Brain hemorrhage
Item
history of hemorrhagic stroke.
boolean
C0553692 (UMLS CUI [1])
Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Condition Familial Interferes with Protocol Compliance | Condition Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up
Item
psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C3850138 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3850138 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])
Allergic Reaction Compound Atorvastatin Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0286651 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
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