ID

14769

Description

PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe); ODM derived from: https://clinicaltrials.gov/show/NCT02269813

Link

https://clinicaltrials.gov/show/NCT02269813

Keywords

Versions (1)
  1. 4/27/16 4/27/16 -
Uploaded on

April 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02269813

English

Eligibility Breast Cancer NCT02269813

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically proven invasive stage 1 and 2 breast cancer
Description

Gender | Invasive breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
hormone receptor positive according to local standards
Description

Hormone Receptor Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1446409
her2 negative - i.e. ihc 0-1+, or fish or other ish non-amplified (locally assessed)
Description

Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1]
C2316304
UMLS CUI [2]
C0021044
UMLS CUI [3]
C0162789
axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm or micro metastases i.e. >0.2-2mm)
Description

axillary lymph node Status | Macrometastasis | Neoplasm Micrometastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1279048
UMLS CUI [1,2]
C0449438
UMLS CUI [2]
C3829229
UMLS CUI [3]
C1513276
≥ 18 years of age at time of consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
Description

eligible Adjuvant Chemotherapy Hormone Therapy | Karnofsky Performance Status | Medical contraindication Hematological Disease Heart Diseases Liver diseases | Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0085533
UMLS CUI [1,3]
C0279025
UMLS CUI [2]
C0206065
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0018939
UMLS CUI [3,3]
C0018799
UMLS CUI [3,4]
C0023895
UMLS CUI [4]
C0009488
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
≥4 involved axillary nodes
Description

Axillary lymph node group

Data type

boolean

Alias
UMLS CUI [1]
C0729594
multi-centric disease with more than 2 clinically relevant lesions
Description

Multicentric Breast Carcinoma Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C2986664
UMLS CUI [1,2]
C0221198
hr negative or her2 positive/amplified (locally assessed)
Description

Hormone Receptor Negative | HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0205160
UMLS CUI [2]
C1960398
previous diagnosis of malignancy unless disease free for 10 years
Description

Prior diagnosis Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0006826
metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria
Description

Tumor tissue sample | quality assurance | quality control

Data type

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2]
C0178932
UMLS CUI [3]
C0034378
women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
Description

Gender | Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0678222
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Similar models

Eligibility Breast Cancer NCT02269813

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive breast carcinoma
Item
women with histologically proven invasive stage 1 and 2 breast cancer
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Hormone Receptor Positive
Item
hormone receptor positive according to local standards
boolean
C0019929 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization
Item
her2 negative - i.e. ihc 0-1+, or fish or other ish non-amplified (locally assessed)
boolean
C2316304 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
axillary lymph node Status | Macrometastasis | Neoplasm Micrometastasis
Item
axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm or micro metastases i.e. >0.2-2mm)
boolean
C1279048 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3829229 (UMLS CUI [2])
C1513276 (UMLS CUI [3])
Age
Item
≥ 18 years of age at time of consent
boolean
C0001779 (UMLS CUI [1])
eligible Adjuvant Chemotherapy Hormone Therapy | Karnofsky Performance Status | Medical contraindication Hematological Disease Heart Diseases Liver diseases | Comorbidity
Item
patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
boolean
C1548635 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
C0206065 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0018939 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0023895 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axillary lymph node group
Item
≥4 involved axillary nodes
boolean
C0729594 (UMLS CUI [1])
Multicentric Breast Carcinoma Lesion
Item
multi-centric disease with more than 2 clinically relevant lesions
boolean
C2986664 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Hormone Receptor Negative | HER2-positive carcinoma of breast
Item
hr negative or her2 positive/amplified (locally assessed)
boolean
C0019929 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C1960398 (UMLS CUI [2])
Prior diagnosis Malignant Neoplasms
Item
previous diagnosis of malignancy unless disease free for 10 years
boolean
C0332132 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Tumor tissue sample | quality assurance | quality control
Item
tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria
boolean
C0475358 (UMLS CUI [1])
C0178932 (UMLS CUI [2])
C0034378 (UMLS CUI [3])
Gender | Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma
Item
women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
boolean
C0079399 (UMLS CUI [1])
C0085533 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
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