ID

16416

Descrição

Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00588003

Link

https://clinicaltrials.gov/show/NCT00588003

Palavras-chave

Versões (1)
  1. 15/07/2016 15/07/2016 -
Transferido a

15 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00588003

Inglês

Eligibility Breast Cancer NCT00588003

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal patients, defined as one or more of the following criteria:
Descrição

Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
documented history of bilateral oophorectomy, aged 60 years or more,
Descrição

Bilateral oophorectomy | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2]
C0001779
aged 45-59 years and satisfying one or more of the following criteria:
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
amenorrhea for at least 12 months and intact uterus amenorrhea for less than 12 months and follicle stimulating hormone (fsh) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past.
Descrição

Duration Amenorrhea | Duration Amenorrhea Uterus Intact | Follicle Stimulating Hormone Concentration Postmenopausal state | Hysterectomy | Hormone replacement therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0002453
UMLS CUI [2,1]
C0449238
UMLS CUI [2,2]
C0002453
UMLS CUI [2,3]
C0042149
UMLS CUI [2,4]
C0205266
UMLS CUI [3,1]
C0733758
UMLS CUI [3,2]
C1446561
UMLS CUI [3,3]
C0232970
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0282402
clinically palpable or non-palpable t1c or greater, er positive invasive breast cancer diagnosed by outside core biopsy.
Descrição

T1c Palpable | TNM clinical staging | Invasive carcinoma of breast Estrogen receptor positive | Core biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475386
UMLS CUI [1,2]
C0522499
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279754
UMLS CUI [4]
C1318309
outside diagnosis of invasive breast cancer confirmed at mskcc
Descrição

Invasive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0853879
palpable or non-palpable breast mass > 1cm highly suspicious for invasive breast cancer based on mammographic, ultrasound and/or physical examination findings and amenable to diagnostic core biopsy.
Descrição

Mass in breast size Palpable | Invasive carcinoma of breast Suspicious High | Mammography | Ultrasonics (sound) | Physical Examination | Core biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024103
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0522499
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0205250
UMLS CUI [3]
C0024671
UMLS CUI [4]
C1456803
UMLS CUI [5]
C0031809
UMLS CUI [6]
C1318309
core biopsy diagnosis of er positive invasive breast cancer performed at mskcc
Descrição

Invasive carcinoma of breast Estrogen receptor positive | Core biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0279754
UMLS CUI [2]
C1318309
breast conserving surgery or mastectomy scheduled at mskcc.
Descrição

Breast-Conserving Surgery | Mastectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0024881
informed consent obtained.
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-morbid conditions which would preclude use of aromatase inhibitors such as: previous hypersensitivity, severe hepatic insufficiency (sgot or sgpt three times the upper limit of normal), severe renal insufficiency (creatinine clearance <10ml/min).
Descrição

Comorbidity Exclusion Aromatase Inhibitors | Hypersensitivity | Hepatic Insufficiency Severe | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal Insufficiency Severe | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0593802
UMLS CUI [2]
C0020517
UMLS CUI [3,1]
C1306571
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6,1]
C1565489
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0373595
prior radiation therapy to chest wall / breast.
Descrição

Therapeutic radiology procedure Chest wall | Therapeutic radiology procedure Breast

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1279035
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0006141
neoadjuvant chemotherapy
Descrição

Chemotherapy Neoadjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months
Descrição

Hormone replacement therapy | Tamoxifen | Raloxifene

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0244404
er negative breast cancer
Descrição

Breast Carcinoma Estrogen receptor negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279756
history of active malignancy within the previous 5 years (except for nonmelanoma skin cancer and breast cancer)
Descrição

Malignant Neoplasms | Skin carcinoma | Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0678222
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Similar models

Eligibility Breast Cancer NCT00588003

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal patients, defined as one or more of the following criteria:
boolean
C0232970 (UMLS CUI [1])
Bilateral oophorectomy | Age
Item
documented history of bilateral oophorectomy, aged 60 years or more,
boolean
C0278321 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Age
Item
aged 45-59 years and satisfying one or more of the following criteria:
boolean
C0001779 (UMLS CUI [1])
Duration Amenorrhea | Duration Amenorrhea Uterus Intact | Follicle Stimulating Hormone Concentration Postmenopausal state | Hysterectomy | Hormone replacement therapy
Item
amenorrhea for at least 12 months and intact uterus amenorrhea for less than 12 months and follicle stimulating hormone (fsh) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past.
boolean
C0449238 (UMLS CUI [1,1])
C0002453 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C0002453 (UMLS CUI [2,2])
C0042149 (UMLS CUI [2,3])
C0205266 (UMLS CUI [2,4])
C0733758 (UMLS CUI [3,1])
C1446561 (UMLS CUI [3,2])
C0232970 (UMLS CUI [3,3])
C0020699 (UMLS CUI [4])
C0282402 (UMLS CUI [5])
T1c Palpable | TNM clinical staging | Invasive carcinoma of breast Estrogen receptor positive | Core biopsy
Item
clinically palpable or non-palpable t1c or greater, er positive invasive breast cancer diagnosed by outside core biopsy.
boolean
C0475386 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0853879 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C1318309 (UMLS CUI [4])
Invasive carcinoma of breast
Item
outside diagnosis of invasive breast cancer confirmed at mskcc
boolean
C0853879 (UMLS CUI [1])
Mass in breast size Palpable | Invasive carcinoma of breast Suspicious High | Mammography | Ultrasonics (sound) | Physical Examination | Core biopsy
Item
palpable or non-palpable breast mass > 1cm highly suspicious for invasive breast cancer based on mammographic, ultrasound and/or physical examination findings and amenable to diagnostic core biopsy.
boolean
C0024103 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0522499 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0024671 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C1318309 (UMLS CUI [6])
Invasive carcinoma of breast Estrogen receptor positive | Core biopsy
Item
core biopsy diagnosis of er positive invasive breast cancer performed at mskcc
boolean
C0853879 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C1318309 (UMLS CUI [2])
Breast-Conserving Surgery | Mastectomy
Item
breast conserving surgery or mastectomy scheduled at mskcc.
boolean
C0917927 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
Informed consent
Item
informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Exclusion Aromatase Inhibitors | Hypersensitivity | Hepatic Insufficiency Severe | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal Insufficiency Severe | Creatinine clearance measurement
Item
co-morbid conditions which would preclude use of aromatase inhibitors such as: previous hypersensitivity, severe hepatic insufficiency (sgot or sgpt three times the upper limit of normal), severe renal insufficiency (creatinine clearance <10ml/min).
boolean
C0009488 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0593802 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2])
C1306571 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1565489 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0373595 (UMLS CUI [7])
Therapeutic radiology procedure Chest wall | Therapeutic radiology procedure Breast
Item
prior radiation therapy to chest wall / breast.
boolean
C1522449 (UMLS CUI [1,1])
C1279035 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
Chemotherapy Neoadjuvant
Item
neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
Hormone replacement therapy | Tamoxifen | Raloxifene
Item
hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months
boolean
C0282402 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0244404 (UMLS CUI [3])
Breast Carcinoma Estrogen receptor negative
Item
er negative breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
Malignant Neoplasms | Skin carcinoma | Breast Carcinoma
Item
history of active malignancy within the previous 5 years (except for nonmelanoma skin cancer and breast cancer)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0678222 (UMLS CUI [3])
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