ID

38350

Descripción

Genomic Signatures to Predict Treatment Response; ODM derived from: https://clinicaltrials.gov/show/NCT02032745

Link

https://clinicaltrials.gov/show/NCT02032745

Palabras clave

Versiones (1)
  1. 11/10/19 11/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02032745

Inglés

Eligibility Breast Neoplasms NCT02032745

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical status of lymph nodes must be available
Descripción

Lymph nodes Clinical status Available

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0449440
UMLS CUI [1,3]
C0470187
sonographical status of lymph nodes must be available
Descripción

Lymph nodes Ultrasonography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0041618
patients must consent to documentation of cancer treatment
Descripción

Consent Documentation Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0920425
histologic diagnosis of invasive breast cancer, clinical stage t1-4, m0 (non-inflammatory t4c)
Descripción

Invasive carcinoma of breast TNM Breast tumor staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
patients scheduled for neoadjuvant chemotherapy
Descripción

Neoadjuvant Chemotherapy Scheduled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0205539
treatment with a 3-weekly fec or ac regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
Descripción

FEC protocol | Adriamycin-Cytoxan Regimen Course Quantity | docetaxel | Paclitaxel

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0060133
UMLS CUI [2,1]
C1879503
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0246415
UMLS CUI [4]
C0144576
local her2 status of tumor biopsy must be negative.
Descripción

HER2 Negative Biopsy Neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0027651
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has a prior history of invasive or metastatic breast cancer.
Descripción

Invasive carcinoma of breast Previous | Secondary malignant neoplasm of female breast Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0205156
the patient had prior excisional biopsy of the primary invasive breast cancer.
Descripción

Excision biopsy Previous Invasive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184921
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0853879
the patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
Descripción

Sentinel Lymph Node Biopsy Axillary Ipsilateral | Sentinel Lymph Node Biopsy Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0004454
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0796693
UMLS CUI [2,2]
C0678222
the patient cannot safely or feasibly undergo biopsy of the primary tumor.
Descripción

Biopsy Primary tumor | Biopsy Receive Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
the patient has a diagnosis of stage iv (distant metastatic) breast cancer.
Descripción

Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346993
the patient has proven her2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
Descripción

HER2-positive carcinoma of breast Immunohistochemistry | HER2 gene amplification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0021044
UMLS CUI [2]
C1512127
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Similar models

Eligibility Breast Neoplasms NCT02032745

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Lymph nodes Clinical status Available
Item
clinical status of lymph nodes must be available
boolean
C0024204 (UMLS CUI [1,1])
C0449440 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Lymph nodes Ultrasonography
Item
sonographical status of lymph nodes must be available
boolean
C0024204 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
Consent Documentation Cancer treatment
Item
patients must consent to documentation of cancer treatment
boolean
C1511481 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Invasive carcinoma of breast TNM Breast tumor staging
Item
histologic diagnosis of invasive breast cancer, clinical stage t1-4, m0 (non-inflammatory t4c)
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Neoadjuvant Chemotherapy Scheduled
Item
patients scheduled for neoadjuvant chemotherapy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
FEC protocol | Adriamycin-Cytoxan Regimen Course Quantity | docetaxel | Paclitaxel
Item
treatment with a 3-weekly fec or ac regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
boolean
C0060133 (UMLS CUI [1])
C1879503 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0246415 (UMLS CUI [3])
C0144576 (UMLS CUI [4])
HER2 Negative Biopsy Neoplasm
Item
local her2 status of tumor biopsy must be negative.
boolean
C2348908 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Previous | Secondary malignant neoplasm of female breast Previous
Item
the patient has a prior history of invasive or metastatic breast cancer.
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Excision biopsy Previous Invasive carcinoma of breast
Item
the patient had prior excisional biopsy of the primary invasive breast cancer.
boolean
C0184921 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0853879 (UMLS CUI [1,3])
Sentinel Lymph Node Biopsy Axillary Ipsilateral | Sentinel Lymph Node Biopsy Breast Carcinoma
Item
the patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
boolean
C0796693 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0796693 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Biopsy Primary tumor | Biopsy Receive Unable
Item
the patient cannot safely or feasibly undergo biopsy of the primary tumor.
boolean
C0005558 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Secondary malignant neoplasm of female breast
Item
the patient has a diagnosis of stage iv (distant metastatic) breast cancer.
boolean
C0346993 (UMLS CUI [1])
HER2-positive carcinoma of breast Immunohistochemistry | HER2 gene amplification
Item
the patient has proven her2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2])
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