ID

41161

Descripción

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

Palabras clave

Versiones (1)
  1. 3/7/20 3/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de julio de 2020

DOI

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Licencia

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

Inglés

Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Locally advanced breast cancer

Tipo de datos

boolean

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

Tumor size | Positive Lymph Node | Needle biopsy Required

Tipo de datos

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
Descripción

Disease Without Neoplasm Metastasis | Computed Tomography | Bone scintigraphy

Tipo de datos

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
Descripción

Histopathologic Grade | Ki67 Measurement

Tipo de datos

boolean

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

Histopathologic Grade

Tipo de datos

boolean

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

Triple-Negative Breast Cancer

Tipo de datos

boolean

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

Inflammatory Breast Carcinoma

Tipo de datos

boolean

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

Left ventricular ejection fraction Normal

Tipo de datos

boolean

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

Disease HER2 Negative

Tipo de datos

boolean

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

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)
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Left ventricular ejection fraction decreased

Tipo de datos

boolean

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

Lobular Carcinoma Histology predominant

Tipo de datos

boolean

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

Histopathologic Grade

Tipo de datos

boolean

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

Distant metastasis | Distant metastasis Suspected

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Gender

Tipo de datos

boolean

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

HER2-positive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960398
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Similar models

Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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