ID

16383

Description

Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00429247

Link

https://clinicaltrials.gov/show/NCT00429247

Keywords

Versions (1)
  1. 7/14/16 7/14/16 -
Uploaded on

July 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00429247

English

Eligibility Breast Cancer NCT00429247

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status (world health organization [who]) < 3
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal) and renal function ( creatinine < 2 mg/dl)
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
adequate cardiac function (left ventricular ejection fraction [lvef] > 50%).
Description

Cardiac function | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
histologically or cytologically confirmed breast adenocarcinoma
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
prior surgical excision of the primary breast tumor
Description

Excision Primary malignant neoplasm of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1299258
prior completion of standard adjuvant chemotherapy and/or radiotherapy
Description

Adjuvant Chemotherapy Complete | Adjuvant Radiotherapy Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0242939
UMLS CUI [2,2]
C0205197
locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
Description

Locally Advanced Malignant Neoplasm | Neoadjuvant Chemotherapy Complete | Excision | Therapeutic radiology procedure | Localized Malignant Neoplasm Evidence of | Metastatic Neoplasm Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0677984
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C0728940
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C0796563
UMLS CUI [5,2]
C0332120
UMLS CUI [6,1]
C2939420
UMLS CUI [6,2]
C0332120
absence of any clinical or laboratory evidence of metastatic disease
Description

Metastatic Neoplasm Evidence Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0332197
detection of ctcs and/or dtcs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
Description

Circulating Tumor Cells Detection | Disseminated Tumor Cells Detection | Chemotherapy, Adjuvant | Radiotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0027625
UMLS CUI [1,2]
C1511790
UMLS CUI [2,1]
C3273605
UMLS CUI [2,2]
C1511790
UMLS CUI [3]
C0085533
UMLS CUI [4]
C0242939
expression of her2/c-neu on the primary tumor is not mandatory
Description

HER-2 neu Expression primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0242957
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0677930
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Description

Malignant Neoplasm Invasive | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0699893
other concurrent uncontrolled illness
Description

Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
psychiatric illness or social situation that would preclude study compliance
Description

Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive pregnancy test
Description

Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0240802
history of allergic reaction attributed to trastuzumab (herceptin)
Description

Allergic Reaction trastuzumab | Allergic Reaction Herceptin

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0338204
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Similar models

Eligibility Breast Cancer NCT00429247

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >= 18 years.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
performance status (world health organization [who]) < 3
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal) and renal function ( creatinine < 2 mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction
Item
adequate cardiac function (left ventricular ejection fraction [lvef] > 50%).
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Breast adenocarcinoma
Item
histologically or cytologically confirmed breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1])
Excision Primary malignant neoplasm of breast
Item
prior surgical excision of the primary breast tumor
boolean
C0728940 (UMLS CUI [1,1])
C1299258 (UMLS CUI [1,2])
Adjuvant Chemotherapy Complete | Adjuvant Radiotherapy Complete
Item
prior completion of standard adjuvant chemotherapy and/or radiotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0242939 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Locally Advanced Malignant Neoplasm | Neoadjuvant Chemotherapy Complete | Excision | Therapeutic radiology procedure | Localized Malignant Neoplasm Evidence of | Metastatic Neoplasm Evidence of
Item
locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
boolean
C0677984 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0796563 (UMLS CUI [5,1])
C0332120 (UMLS CUI [5,2])
C2939420 (UMLS CUI [6,1])
C0332120 (UMLS CUI [6,2])
Metastatic Neoplasm Evidence Absent
Item
absence of any clinical or laboratory evidence of metastatic disease
boolean
C2939420 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Circulating Tumor Cells Detection | Disseminated Tumor Cells Detection | Chemotherapy, Adjuvant | Radiotherapy, Adjuvant
Item
detection of ctcs and/or dtcs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
boolean
C0027625 (UMLS CUI [1,1])
C1511790 (UMLS CUI [1,2])
C3273605 (UMLS CUI [2,1])
C1511790 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0242939 (UMLS CUI [4])
HER-2 neu Expression primary tumor
Item
expression of her2/c-neu on the primary tumor is not mandatory
boolean
C0242957 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Invasive | Skin carcinoma
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
Illness Uncontrolled
Item
other concurrent uncontrolled illness
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test positive
Item
positive pregnancy test
boolean
C0240802 (UMLS CUI [1])
Allergic Reaction trastuzumab | Allergic Reaction Herceptin
Item
history of allergic reaction attributed to trastuzumab (herceptin)
boolean
C1527304 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0338204 (UMLS CUI [2,2])
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