ID

19632

Beskrivning

Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00533936

Länk

https://clinicaltrials.gov/show/NCT00533936

Nyckelord

Versioner (1)
  1. 2017-01-17 2017-01-17 -
Uppladdad den

17 januari 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT00533936

Engelsk

Eligibility Breast Cancer NCT00533936

1 Formulär  
Criteria
Beskrivning

Criteria

histologically confirmed invasive breast cancer by needle biopsy
Beskrivning

Invasive carcinoma of breast Needle biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0005560
diagnosed within the past 4 weeks
Beskrivning

Diagnosis Timepoint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C2348792
clinical stage iib, iiia, iiib, or iiic disease
Beskrivning

Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
palpable adenopathies present
Beskrivning

Lymphadenopathy Palpable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0522499
her2/neu-positive disease, as evidenced by either of the following:
Beskrivning

HER2-positive carcinoma of breast Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0332120
her2/neu overexpression (3+) by immunohistochemistry (ihc)
Beskrivning

ERBB2 Protein Overexpression Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
her2/neu amplification by fluorescence in situ hybridization (fish)
Beskrivning

HER2 gene amplification Fluorescent in Situ Hybridization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
no metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
Beskrivning

Neoplasm Metastasis Plain chest X-ray | Ultrasonography of liver | Radioisotope scan of bone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0039985
UMLS CUI [2]
C0412534
UMLS CUI [3]
C0203668
hormone receptor status:
Beskrivning

Hormone Receptor Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
estrogen receptor and/or progesterone receptor status known
Beskrivning

Estrogen Receptor Status Known | Progesterone Receptor Status Known

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
premenopausal or postmenopausal
Beskrivning

Premenopausal state | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
who performance status 0-2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
not pregnant or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
normal hepatic, renal, and hematological function
Beskrivning

Liver function | Renal function | Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
lvef ≥ 55% by nuclear medicine study or echocardiogram
Beskrivning

Left ventricular ejection fraction Nuclear medicine procedure | Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0203634
UMLS CUI [2]
C0013516
no prior history of cancer, except carcinoma in situ of the cervix
Beskrivning

Malignant Neoplasms | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
no allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (herceptin®)
Beskrivning

Paclitaxel allergy | Hypersensitivity trastuzumab | Hypersensitivity Herceptin

Datatyp

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0338204
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
no prior cancer therapy
Beskrivning

cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT00533936

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Invasive carcinoma of breast Needle biopsy
Item
histologically confirmed invasive breast cancer by needle biopsy
boolean
C0853879 (UMLS CUI [1,1])
C0005560 (UMLS CUI [1,2])
Diagnosis Timepoint
Item
diagnosed within the past 4 weeks
boolean
C0011900 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
clinical stage iib, iiia, iiib, or iiic disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lymphadenopathy Palpable
Item
palpable adenopathies present
boolean
C0497156 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
HER2-positive carcinoma of breast Evidence of
Item
her2/neu-positive disease, as evidenced by either of the following:
boolean
C1960398 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
ERBB2 Protein Overexpression Immunohistochemistry
Item
her2/neu overexpression (3+) by immunohistochemistry (ihc)
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 gene amplification Fluorescent in Situ Hybridization
Item
her2/neu amplification by fluorescence in situ hybridization (fish)
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Neoplasm Metastasis Plain chest X-ray | Ultrasonography of liver | Radioisotope scan of bone
Item
no metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
boolean
C0027627 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0412534 (UMLS CUI [2])
C0203668 (UMLS CUI [3])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Estrogen Receptor Status Known | Progesterone Receptor Status Known
Item
estrogen receptor and/or progesterone receptor status known
boolean
C0034804 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0034833 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Premenopausal state | Postmenopausal state
Item
premenopausal or postmenopausal
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver function | Renal function | Hematologic function
Item
normal hepatic, renal, and hematological function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Left ventricular ejection fraction Nuclear medicine procedure | Echocardiography
Item
lvef ≥ 55% by nuclear medicine study or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0203634 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix
Item
no prior history of cancer, except carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
Paclitaxel allergy | Hypersensitivity trastuzumab | Hypersensitivity Herceptin
Item
no allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (herceptin®)
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
cancer treatment
Item
no prior cancer therapy
boolean
C0920425 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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