ID

41161

Beschrijving

Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01329627

Link

https://clinicaltrials.gov/show/NCT01329627

Trefwoorden

Versies (1)
  1. 03-07-20 03-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 juli 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

Engels

Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced breast cancer diagnosed by guided core biopsy
Beschrijving

Locally advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C3495949
t > 2 cm (any n), or any t and node positive (needle biopsy is required)
Beschrijving

Tumor size | Positive Lymph Node | Needle biopsy Required

Datatype

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0746319
UMLS CUI [3,1]
C0005560
UMLS CUI [3,2]
C1514873
non-metastatic disease assessed by computed tomography and bone scintigraphy
Beschrijving

Disease Without Neoplasm Metastasis | Computed Tomography | Bone scintigraphy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0027627
UMLS CUI [2]
C0040405
UMLS CUI [3]
C3889015
histological grade 2 and ki67 > 15% or
Beschrijving

Histopathologic Grade | Ki67 Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0919553
UMLS CUI [2]
C4049944
histological grade 3 or
Beschrijving

Histopathologic Grade

Datatype

boolean

Alias
UMLS CUI [1]
C0919553
any triple negative (tn) or
Beschrijving

Triple-Negative Breast Cancer

Datatype

boolean

Alias
UMLS CUI [1]
C2348819
inflammatory breast cancer (ibc)
Beschrijving

Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
normal left ventricular ejection fraction (lvef)
Beschrijving

Left ventricular ejection fraction Normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
her2-negative disease
Beschrijving

Disease HER2 Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348908
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
Beschrijving

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Ductal carcinoma in situ of breast | Exception Curative treatment Lobular carcinoma in situ of breast

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0279563
clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (copd), renal or liver failure, psychiatric disorders
Beschrijving

Comorbidity Clinical Significance | Cardiovascular Diseases | Chronic Obstructive Airway Disease | Kidney Failure | Liver Failure | Mental disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024117
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0085605
UMLS CUI [6]
C0004936
lvef value below institutional limits of normal
Beschrijving

Left ventricular ejection fraction decreased

Datatype

boolean

Alias
UMLS CUI [1]
C1096403
predominant lobular carcinoma histology
Beschrijving

Lobular Carcinoma Histology predominant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0206692
UMLS CUI [1,2]
C0344441
UMLS CUI [1,3]
C1542147
grade 1 tumors
Beschrijving

Histopathologic Grade

Datatype

boolean

Alias
UMLS CUI [1]
C0919553
detected or suspicious distant metastasis
Beschrijving

Distant metastasis | Distant metastasis Suspected

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0750491
neutrophils less than 1,500/µl, platelets less than 100,000/µl, hemoglobin less than 10 g/dl, ast more than 2.5x upper limit of normal (uln), total bilirubin more than uln, alkaline phosphatase more than 1.5x uln
Beschrijving

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate Aminotransferase Increased | SERUM TOTAL BILIRUBIN ELEVATED | Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0595866
UMLS CUI [6]
C0151849
male sex
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
her2-positive breast cancer
Beschrijving

HER2-positive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
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Similar models

Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer
Item
locally advanced breast cancer diagnosed by guided core biopsy
boolean
C3495949 (UMLS CUI [1])
Tumor size | Positive Lymph Node | Needle biopsy Required
Item
t > 2 cm (any n), or any t and node positive (needle biopsy is required)
boolean
C0475440 (UMLS CUI [1])
C0746319 (UMLS CUI [2])
C0005560 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Disease Without Neoplasm Metastasis | Computed Tomography | Bone scintigraphy
Item
non-metastatic disease assessed by computed tomography and bone scintigraphy
boolean
C0012634 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C3889015 (UMLS CUI [3])
Histopathologic Grade | Ki67 Measurement
Item
histological grade 2 and ki67 > 15% or
boolean
C0919553 (UMLS CUI [1])
C4049944 (UMLS CUI [2])
Histopathologic Grade
Item
histological grade 3 or
boolean
C0919553 (UMLS CUI [1])
Triple-Negative Breast Cancer
Item
any triple negative (tn) or
boolean
C2348819 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer (ibc)
boolean
C0278601 (UMLS CUI [1])
Left ventricular ejection fraction Normal
Item
normal left ventricular ejection fraction (lvef)
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Disease HER2 Negative
Item
her2-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Ductal carcinoma in situ of breast | Exception Curative treatment Lobular carcinoma in situ of breast
Item
another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0279563 (UMLS CUI [5,3])
Comorbidity Clinical Significance | Cardiovascular Diseases | Chronic Obstructive Airway Disease | Kidney Failure | Liver Failure | Mental disorders
Item
clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (copd), renal or liver failure, psychiatric disorders
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0085605 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Left ventricular ejection fraction decreased
Item
lvef value below institutional limits of normal
boolean
C1096403 (UMLS CUI [1])
Lobular Carcinoma Histology predominant
Item
predominant lobular carcinoma histology
boolean
C0206692 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Histopathologic Grade
Item
grade 1 tumors
boolean
C0919553 (UMLS CUI [1])
Distant metastasis | Distant metastasis Suspected
Item
detected or suspicious distant metastasis
boolean
C1269798 (UMLS CUI [1])
C1269798 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate Aminotransferase Increased | SERUM TOTAL BILIRUBIN ELEVATED | Alkaline phosphatase raised
Item
neutrophils less than 1,500/µl, platelets less than 100,000/µl, hemoglobin less than 10 g/dl, ast more than 2.5x upper limit of normal (uln), total bilirubin more than uln, alkaline phosphatase more than 1.5x uln
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0595866 (UMLS CUI [5])
C0151849 (UMLS CUI [6])
Gender
Item
male sex
boolean
C0079399 (UMLS CUI [1])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
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