ID

16421

Beskrivning

Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00615602

Länk

https://clinicaltrials.gov/show/NCT00615602

Nyckelord

Versioner (1)
  1. 2016-07-15 2016-07-15 -
Uppladdad den

15 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00615602

Engelsk

Eligibility Breast Cancer NCT00615602

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
Beskrivning

Gender | Invasive Ductal Breast Carcinoma Unilateral | Breast adenocarcinoma Lobular

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C0858252
UMLS CUI [3,2]
C0205417
her2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or fish/cish positivity. a score of 2+ by immunohistochemistry is acceptable only if fish/cish positive
Beskrivning

her-2/neu Protein Overexpression | Immunohistochemistry Score | Fluorescent in Situ Hybridization Positive | Chromogenic in situ Hybridization Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242957
UMLS CUI [1,2]
C1514559
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0449820
UMLS CUI [3,1]
C0162789
UMLS CUI [3,2]
C1446409
UMLS CUI [4,1]
C1516514
UMLS CUI [4,2]
C1446409
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
Beskrivning

Excision primary tumor | Surgical margin uninvolved by tumor | Requirement Excision of axillary lymph nodes Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0332648
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0193867
UMLS CUI [3,3]
C1265611
tumor involvement of at least one axillary lymph node (n0 with her2/c-neu over expression are also eligible)
Beskrivning

Axillary lymph node Involvement with Neoplasms | Node stage N0 her-2/neu Protein Overexpression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0027651
UMLS CUI [2,1]
C0441959
UMLS CUI [2,2]
C0242957
UMLS CUI [2,3]
C1514559
absence of any clinical or radiological evidence of local or metastatic disease
Beskrivning

Local disease Evidence of | Metastatic Neoplasm Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0332120
premenopausal or postmenopausal women aged 18-75 years old
Beskrivning

Premenopausal | Postmenopausal state | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
Beskrivning

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

Datatyp

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 <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
Beskrivning

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

Datatyp

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 (lvef>50%). normal electrocardiogram and absence of significant heart disease
Beskrivning

Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Significant Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0522054
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0750502
UMLS CUI [4,3]
C0332197
written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive pregnancy test.
Beskrivning

Pregnancy test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
psychiatric illness or social situation that would preclude study compliance.
Beskrivning

Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datatyp

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
other concurrent uncontrolled illness.
Beskrivning

Illness Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
Beskrivning

Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors

Datatyp

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0005515
previous history of other invasive malignancy other than non-melanomatous skin cancer.
Beskrivning

invasive cancer | Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT00615602

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive Ductal Breast Carcinoma Unilateral | Breast adenocarcinoma Lobular
Item
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C1134719 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0858252 (UMLS CUI [3,1])
C0205417 (UMLS CUI [3,2])
her-2/neu Protein Overexpression | Immunohistochemistry Score | Fluorescent in Situ Hybridization Positive | Chromogenic in situ Hybridization Positive
Item
her2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or fish/cish positivity. a score of 2+ by immunohistochemistry is acceptable only if fish/cish positive
boolean
C0242957 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162789 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C1516514 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
Excision primary tumor | Surgical margin uninvolved by tumor | Requirement Excision of axillary lymph nodes Quantity
Item
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332648 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0193867 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Axillary lymph node Involvement with Neoplasms | Node stage N0 her-2/neu Protein Overexpression
Item
tumor involvement of at least one axillary lymph node (n0 with her2/c-neu over expression are also eligible)
boolean
C0729594 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0441959 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C1514559 (UMLS CUI [2,3])
Local disease Evidence of | Metastatic Neoplasm Evidence of
Item
absence of any clinical or radiological evidence of local or metastatic disease
boolean
C0277565 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2939420 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Premenopausal | Postmenopausal state | Age
Item
premenopausal or postmenopausal women aged 18-75 years old
boolean
C0279752 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
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 <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/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 | ECG normal | Heart Disease Significant Absent
Item
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0522054 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy test positive
Item
positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
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])
Illness Uncontrolled
Item
other concurrent uncontrolled illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors
Item
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
boolean
C2346834 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
invasive cancer | Skin carcinoma
Item
previous history of other invasive malignancy other than non-melanomatous skin cancer.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Tillbaka till toppen 

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