ID

36078

Beschrijving

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population; ODM derived from: https://clinicaltrials.gov/show/NCT02347449

Link

https://clinicaltrials.gov/show/NCT02347449

Trefwoorden

Versies (1)
  1. 14-04-19 14-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT02347449

Engels

Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT02347449

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
Beschrijving

Operative Surgical Procedures Breast Carcinoma | Sentinel Lymph Node Biopsy | Axillary lymph nodes Dissection Full | Axillary lymph nodes Quantity Involvement Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0796693
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C0012737
UMLS CUI [3,3]
C0443225
UMLS CUI [4,1]
C0729594
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1314939
UMLS CUI [4,4]
C1514241
ecog performance status 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
Beschrijving

Cancer treatment | Systemic Chemotherapy In addition to Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0279025
eligible staging criteria: t1-3 n1 m0
Beschrijving

TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1]
C0474926
breast tumor must undergo central pathology review at ghi and must be found adequate for the oncotype dx assay.
Beschrijving

Breast Carcinoma Central Pathology Review | Breast Carcinoma Adequate Oncotype DX Breast Cancer Assay

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2347585
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205411
UMLS CUI [2,3]
C1709318
breast tumor must be estrogen-receptor positive and her2 positive (ihc/fish) as per institutional guidelines
Beschrijving

Breast Carcinoma Estrogen receptor positive Immunohistochemistry | Breast Carcinoma HER2 Positive Immunohistochemistry | Breast Carcinoma Estrogen receptor positive FISH | Breast Carcinoma HER2 Positive FISH

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C0162789
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C2348909
UMLS CUI [4,3]
C0162789
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a prior history of breast cancer in the same breast
Beschrijving

Medical History Breast Carcinoma Breast Same

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0445247
patient as been newly diagnosed with more than one operable primary breast tumor
Beschrijving

Breast Carcinoma Operable Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205188
UMLS CUI [1,3]
C1265611
patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
Beschrijving

Multicentric Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2986664
patient has known metastatic breast cancer
Beschrijving

Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
patient has <2mm invasive tumor as assessed by local pathologist
Beschrijving

Invasive Carcinoma Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1334274
UMLS CUI [1,2]
C0456389
patient has received any kind of neoadjuvant treatment
Beschrijving

Neoadjuvant Therapy Kind Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy
Beschrijving

Patient Inappropriate Adjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0085533
presence of a current medical condition that would interfere with patient's ability to consent and participate in this study
Beschrijving

Medical condition Interferes with Informed Consent | Medical condition Interferes with Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
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Similar models

Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT02347449

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedures Breast Carcinoma | Sentinel Lymph Node Biopsy | Axillary lymph nodes Dissection Full | Axillary lymph nodes Quantity Involvement Positive
Item
patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0796693 (UMLS CUI [2])
C0729594 (UMLS CUI [3,1])
C0012737 (UMLS CUI [3,2])
C0443225 (UMLS CUI [3,3])
C0729594 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
C1514241 (UMLS CUI [4,4])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Cancer treatment | Systemic Chemotherapy In addition to Hormone Therapy
Item
patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
boolean
C0920425 (UMLS CUI [1])
C1883256 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
TNM Breast tumor staging
Item
eligible staging criteria: t1-3 n1 m0
boolean
C0474926 (UMLS CUI [1])
Breast Carcinoma Central Pathology Review | Breast Carcinoma Adequate Oncotype DX Breast Cancer Assay
Item
breast tumor must undergo central pathology review at ghi and must be found adequate for the oncotype dx assay.
boolean
C0678222 (UMLS CUI [1,1])
C2347585 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C1709318 (UMLS CUI [2,3])
Breast Carcinoma Estrogen receptor positive Immunohistochemistry | Breast Carcinoma HER2 Positive Immunohistochemistry | Breast Carcinoma Estrogen receptor positive FISH | Breast Carcinoma HER2 Positive FISH
Item
breast tumor must be estrogen-receptor positive and her2 positive (ihc/fish) as per institutional guidelines
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C0162789 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Medical History Breast Carcinoma Breast Same
Item
patient has a prior history of breast cancer in the same breast
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0445247 (UMLS CUI [1,4])
Breast Carcinoma Operable Quantity
Item
patient as been newly diagnosed with more than one operable primary breast tumor
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Multicentric Breast Carcinoma
Item
patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
boolean
C2986664 (UMLS CUI [1])
Secondary malignant neoplasm of female breast
Item
patient has known metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Invasive Carcinoma Size
Item
patient has <2mm invasive tumor as assessed by local pathologist
boolean
C1334274 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Neoadjuvant Therapy Kind Any
Item
patient has received any kind of neoadjuvant treatment
boolean
C0600558 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Patient Inappropriate Adjuvant Chemotherapy
Item
presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Study Subject Participation Status
Item
presence of a current medical condition that would interfere with patient's ability to consent and participate in this study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
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