ID

13389

Beschrijving

Neoadjuvant Herceptin in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00133796

Link

https://clinicaltrials.gov/show/NCT00133796

Trefwoorden

Versies (1)
  1. 10-02-16 10-02-16 -
Geüploaded op

10 februari 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00133796

Engels

Eligibility Breast Cancer NCT00133796

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
All patients must be female.
Beschrijving

gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
Informed consent must be signed.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
Beschrijving

locally advanced breast cancers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677984
UMLS CUI [1,2]
C0006141
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0027627
Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
Beschrijving

Her2neu overexpressing tumors

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
Beschrijving

pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0430060
kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
Beschrijving

kidney and liver function tests

Datatype

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C0232741
Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
Beschrijving

performance status and life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
Age > 18.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
No metastatic disease without concomitant primary breast cancer.
Beschrijving

primary breast cancer and metastatic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0027627
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Beschrijving

other malignancies

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Beschrijving

pregnancy and contraceptive use

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
Severe underlying chronic illness or disease.
Beschrijving

severe comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
Beschrijving

cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2]
C0428772
Patients on other investigational drugs while on study.
Beschrijving

participation in another trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
Beschrijving

hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0005823
History of congestive heart failure.
Beschrijving

history of CHF

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
History of coronary arterial disease.
Beschrijving

history of CAD

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00133796

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
All patients must be female.
boolean
C0079399 (UMLS CUI [1])
informed consent
Item
Informed consent must be signed.
boolean
C0021430 (UMLS CUI [1])
locally advanced breast cancers
Item
Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
boolean
C0677984 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Her2neu overexpressing tumors
Item
Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
boolean
C1960398 (UMLS CUI [1])
pregnancy test
Item
Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
boolean
C0430060 (UMLS CUI [1])
kidney and liver function tests
Item
kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
boolean
C0232805 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
performance status and life expectancy
Item
Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
age
Item
Age > 18.
boolean
C0001779 (UMLS CUI [1])
primary breast cancer and metastatic disease
Item
No metastatic disease without concomitant primary breast cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
other malignancies
Item
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy and contraceptive use
Item
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
severe comorbidity
Item
Severe underlying chronic illness or disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
cardiomyopathy
Item
Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
participation in another trial
Item
Patients on other investigational drugs while on study.
boolean
C2348568 (UMLS CUI [1])
hypertension
Item
Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
history of CHF
Item
History of congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
history of CAD
Item
History of coronary arterial disease.
boolean
C1956346 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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