ID

38350

Description

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

Link

https://clinicaltrials.gov/show/NCT02032745

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02032745

English

Eligibility Breast Neoplasms NCT02032745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Lymph nodes Clinical status Available

Data type

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
Description

Lymph nodes Ultrasonography

Data type

boolean

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

Consent Documentation Cancer treatment

Data type

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)
Description

Invasive carcinoma of breast TNM Breast tumor staging

Data type

boolean

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

Neoadjuvant Chemotherapy Scheduled

Data type

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.
Description

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

Data type

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.
Description

HER2 Negative Biopsy Neoplasm

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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.
Description

Excision biopsy Previous Invasive carcinoma of breast

Data type

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.
Description

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

Data type

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.
Description

Biopsy Primary tumor | Biopsy Receive Unable

Data type

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.
Description

Secondary malignant neoplasm of female breast

Data type

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.
Description

HER2-positive carcinoma of breast Immunohistochemistry | HER2 gene amplification

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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