ID

20406

Beschrijving

Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT00532857

Link

https://clinicaltrials.gov/show/NCT00532857

Trefwoorden

Versies (1)
  1. 21-02-17 21-02-17 -
Geüploaded op

21 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00532857

Engels

Eligibility Breast Cancer NCT00532857

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have histologically confirmed and newly diagnosed operable breast cancer
Beschrijving

breast carcinoma histologically confirmed and operable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0205188
her2 positive (all fish +)
Beschrijving

her2 positive

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
axillary node positive (by pet or cytologically determine node by sonography) and/or tumor size > 5 cm -no prior hormonal, chemotherapy or radiotherapy is allowed.
Beschrijving

axillary node positive (by pet or cytologically determined node by sonography), tumor size, no prior hormonal, chemotherapy or radiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0741343
UMLS CUI [1,2]
C0032743
UMLS CUI [1,3]
C0010819
UMLS CUI [1,4]
C2315103
UMLS CUI [2]
C0475440
UMLS CUI [3]
C1514463
UMLS CUI [4]
C0877050
UMLS CUI [5]
C0392920
UMLS CUI [6]
C1522449
no breast operation other than biopsy to make diagnosis is allowed.
Beschrijving

Operation on breast | Core needle biopsy of breast

Datatype

boolean

Alias
UMLS CUI [1]
C3714726
UMLS CUI [2]
C0191853
age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
Beschrijving

Age | Pregnancy | Gender | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0079399
UMLS CUI [4]
C1520224
adequate hematopoietic function:
Beschrijving

hematopoietic function

Datatype

boolean

Alias
UMLS CUI [1]
C0541533
absolute granulocyte count ³1500/mm3,
Beschrijving

absolute granulocyte count

Datatype

boolean

Alias
UMLS CUI [1]
C0857490
platelet ³100,000/mm3, hemoglobin ³ 10 g/mm3
Beschrijving

blood platelet, hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0019046
adequate renal function: serum creatinine £ 1.5 mg/dl
Beschrijving

creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
adequate hepatic function: total bilirubin: £ 1.5 mg/dl, ast/alt: £ 2 times normal, alkaline phosphatase: £ 2 times normal-adequate cardiac function:
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement; Alanine aminotransferase measurement | Alkaline phosphatase measurement | Cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C0201899
UMLS CUI [2,2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0232164
1. normal or nonspecific ekg taken within 1 mo of enrollment
Beschrijving

ekg

Datatype

boolean

Alias
UMLS CUI [1]
C1623258
2. lvef ³ 50% by muga or echocardiogram taken within 1 mo of enrollment
Beschrijving

lvef by muga or echocardiogram

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [1,3]
C0521317
normal mental function to understand and sign the consent
Beschrijving

informed consent, normal mental function

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0004936
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Cancer hormonal therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Breast Carcinoma; Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0877050
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C1514463
patients who underwent surgery for breast cancer
Beschrijving

Operation on breast; Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0678222
patients with a history of uncompensated congestive heart failure
Beschrijving

Congestive heart failure; Uncompensated | Medical History

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205433
UMLS CUI [2]
C0262926
patients with node-negative stage iia (t2n0) breast cancer
Beschrijving

Node category finding; Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272457
UMLS CUI [1,2]
C0678222
patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
Beschrijving

Medical History; Malignant Neoplasms | Carcinoma in situ of uterine cervix | Nonmelanoma skin cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C3281209
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Similar models

Eligibility Breast Cancer NCT00532857

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
breast carcinoma histologically confirmed and operable
Item
all patients must have histologically confirmed and newly diagnosed operable breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
her2 positive
Item
her2 positive (all fish +)
boolean
C1960398 (UMLS CUI [1])
axillary node positive (by pet or cytologically determined node by sonography), tumor size, no prior hormonal, chemotherapy or radiotherapy
Item
axillary node positive (by pet or cytologically determine node by sonography) and/or tumor size > 5 cm -no prior hormonal, chemotherapy or radiotherapy is allowed.
boolean
C0741343 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,3])
C2315103 (UMLS CUI [1,4])
C0475440 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
C0877050 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Operation on breast | Core needle biopsy of breast
Item
no breast operation other than biopsy to make diagnosis is allowed.
boolean
C3714726 (UMLS CUI [1])
C0191853 (UMLS CUI [2])
Age | Pregnancy | Gender | ECOG performance status
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:
boolean
C0541533 (UMLS CUI [1])
absolute granulocyte count
Item
absolute granulocyte count ³1500/mm3,
boolean
C0857490 (UMLS CUI [1])
blood platelet, hemoglobin
Item
platelet ³100,000/mm3, hemoglobin ³ 10 g/mm3
boolean
C0005821 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
creatinine
Item
adequate renal function: serum creatinine £ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement; Alanine aminotransferase measurement | Alkaline phosphatase measurement | Cardiac function
Item
adequate hepatic function: total bilirubin: £ 1.5 mg/dl, ast/alt: £ 2 times normal, alkaline phosphatase: £ 2 times normal-adequate cardiac function:
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
C0201850 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
ekg
Item
1. normal or nonspecific ekg taken within 1 mo of enrollment
boolean
C1623258 (UMLS CUI [1])
lvef by muga or echocardiogram
Item
2. lvef ³ 50% by muga or echocardiogram taken within 1 mo of enrollment
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [1,3])
informed consent, normal mental function
Item
normal mental function to understand and sign the consent
boolean
C0021430 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cancer hormonal therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Breast Carcinoma; Prior Therapy
Item
patients who received hormonal, chemotherapy or radiotherapy for breast cancer
boolean
C0877050 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0678222 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
Operation on breast; Breast Carcinoma
Item
patients who underwent surgery for breast cancer
boolean
C3714726 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Congestive heart failure; Uncompensated | Medical History
Item
patients with a history of uncompensated congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
Node category finding; Breast Carcinoma
Item
patients with node-negative stage iia (t2n0) breast cancer
boolean
C1272457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Medical History; Malignant Neoplasms | Carcinoma in situ of uterine cervix | Nonmelanoma skin cancer
Item
patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0851140 (UMLS CUI [2])
C3281209 (UMLS CUI [3])
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