ID

16306

Beschrijving

Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00532285

Link

https://clinicaltrials.gov/show/NCT00532285

Trefwoorden

Versies (1)
  1. 10-07-16 10-07-16 -
Geüploaded op

10 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00532285

Engels

Eligibility Breast Cancer NCT00532285

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage iia and any stage iib, iii. pet results will determine node positivity. if pet was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
Beschrijving

Node-positive breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C0746319
UMLS CUI [1,4]
C0032743
UMLS CUI [1,5]
C0398442
no prior hormonal, chemotherapy or radiotherapy is allowed.
Beschrijving

prior hormonal, chemotherapy or radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C1514457
UMLS CUI [3]
C0279134
no breast operation other than biopsy to make diagnosis is allowed.
Beschrijving

breast operation

Datatype

boolean

Alias
UMLS CUI [1]
C3714726
age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
Beschrijving

age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0079399
UMLS CUI [4]
C1520224
adequate hematopoietic function: absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, hemoglobin ³ 10 g/mm3
Beschrijving

Hematopoietic function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0857490
UMLS CUI [1,2]
C0032181
UMLS CUI [1,3]
C0518015
adequate renal function: serum creatinine £ 1.5 mg/dl
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
adequate hepatic function: total bilirubin: £ 1.5 mg/dl, ast/alt: £ two times normal, alkaline phosphatase: £ two times normal
Beschrijving

Hepatic Function

Datatype

boolean

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C0201836
UMLS CUI [1,4]
C0201850
adequate cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment
Beschrijving

cardiac function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0013798
adequate mental function to understand and sign the consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who received hormonal, chemotherapy or radiotherapy for breast cancer
Beschrijving

prior hormonal, chemotherapy or radiotherapy for breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0279134
UMLS CUI [1,4]
C0678222
patients who underwent surgery for breast cancer
Beschrijving

surgery for breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0678222
patients with node-negative stage iia breast cancer
Beschrijving

Tumor stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C3160889
patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
Beschrijving

history of cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Breast Cancer NCT00532285

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Node-positive breast cancer
Item
all patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage iia and any stage iib, iii. pet results will determine node positivity. if pet was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
boolean
C0678222 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0746319 (UMLS CUI [1,3])
C0032743 (UMLS CUI [1,4])
C0398442 (UMLS CUI [1,5])
prior hormonal, chemotherapy or radiotherapy
Item
no prior hormonal, chemotherapy or radiotherapy is allowed.
boolean
C1514460 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C0279134 (UMLS CUI [3])
breast operation
Item
no breast operation other than biopsy to make diagnosis is allowed.
boolean
C3714726 (UMLS CUI [1])
age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
Item
age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
Hematopoietic function
Item
adequate hematopoietic function: absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, hemoglobin ³ 10 g/mm3
boolean
C0857490 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,3])
Renal function
Item
adequate renal function: serum creatinine £ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Hepatic Function
Item
adequate hepatic function: total bilirubin: £ 1.5 mg/dl, ast/alt: £ two times normal, alkaline phosphatase: £ two times normal
boolean
C1278039 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0201850 (UMLS CUI [1,4])
cardiac function
Item
adequate cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment
boolean
C0232164 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Informed Consent
Item
adequate mental function to understand and sign the consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior hormonal, chemotherapy or radiotherapy for breast cancer
Item
patients who received hormonal, chemotherapy or radiotherapy for breast cancer
boolean
C1514460 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0678222 (UMLS CUI [1,4])
surgery for breast cancer
Item
patients who underwent surgery for breast cancer
boolean
C3714726 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Tumor stage
Item
patients with node-negative stage iia breast cancer
boolean
C1300072 (UMLS CUI [1,1])
C3160889 (UMLS CUI [1,2])
history of cancer
Item
patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
boolean
C0006826 (UMLS CUI [1])
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