ID

40461

Descrição

Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"; ODM derived from: https://clinicaltrials.gov/show/NCT02244580

Link

https://clinicaltrials.gov/show/NCT02244580

Palavras-chave

Versões (1)
  1. 23/04/2020 23/04/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

23 de abril de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Invasive Breast Cancer NCT02244580

Inglês

Eligibility Invasive Breast Cancer NCT02244580

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive breast cancer verified in a histological biopsy
Descrição

Invasive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0853879
age 65 or younger
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
estrogen receptor (er), pgr and her2 expression have been determined
Descrição

Estrogen Receptor Expression Determined | Progesterone Receptor Expression Determined | HER2 Receptor Expression Determined

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0521095
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C0017262
UMLS CUI [2,3]
C0521095
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C0017262
UMLS CUI [3,3]
C0521095
no distant metastases present (m0)
Descrição

Distant metastasis Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
the patient provides a written informed consent for study participation
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
the estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)
Descrição

High risk of Breast cancer recurrent | Risk Percentage Timespan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0278493
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes
Descrição

Mucinous breast cancer | Papillary carcinoma of the breast | Medullary carcinoma of breast | Tubular breast carcinoma | Neoplasm Metastasis Absent Axillary lymph nodes Ipsilateral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0860581
UMLS CUI [2]
C3812899
UMLS CUI [3]
C0860580
UMLS CUI [4]
C1328544
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0729594
UMLS CUI [5,4]
C0441989
the who performance status is moderate/poor, z >1
Descrição

WHO performance status scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
the peripheral blood leukocyte count is less than 3.0 x 109/l, the blood granulocyte count is less than 1.5 x 109/l, or the blood thrombocyte count is less than 120 x 109/l
Descrição

White Blood Cell Count procedure Peripheral blood | Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0229664
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
any physical or mental disorder that is considered to prohibit administration of chemotherapy
Descrição

Physical illness Preventing Chemotherapy | Mental disorders Preventing Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0392920
cardiac failure; severe cardiac arrythmia requiring regular medication
Descrição

Heart failure | Cardiac Arrhythmia Severe | Pharmaceutical Preparations Regular Required

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205272
UMLS CUI [3,3]
C1514873
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Similar models

Eligibility Invasive Breast Cancer NCT02244580

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
invasive breast cancer verified in a histological biopsy
boolean
C0853879 (UMLS CUI [1])
Age
Item
age 65 or younger
boolean
C0001779 (UMLS CUI [1])
Estrogen Receptor Expression Determined | Progesterone Receptor Expression Determined | HER2 Receptor Expression Determined
Item
estrogen receptor (er), pgr and her2 expression have been determined
boolean
C0034804 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])
C0034833 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0521095 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C0017262 (UMLS CUI [3,2])
C0521095 (UMLS CUI [3,3])
Distant metastasis Absent
Item
no distant metastases present (m0)
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
the patient provides a written informed consent for study participation
boolean
C0021430 (UMLS CUI [1])
High risk of Breast cancer recurrent | Risk Percentage Timespan
Item
the estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)
boolean
C0332167 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C0035647 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Mucinous breast cancer | Papillary carcinoma of the breast | Medullary carcinoma of breast | Tubular breast carcinoma | Neoplasm Metastasis Absent Axillary lymph nodes Ipsilateral
Item
patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes
boolean
C0860581 (UMLS CUI [1])
C3812899 (UMLS CUI [2])
C0860580 (UMLS CUI [3])
C1328544 (UMLS CUI [4])
C0027627 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0729594 (UMLS CUI [5,3])
C0441989 (UMLS CUI [5,4])
WHO performance status scale
Item
the who performance status is moderate/poor, z >1
boolean
C1298650 (UMLS CUI [1])
White Blood Cell Count procedure Peripheral blood | Absolute neutrophil count | Platelet Count measurement
Item
the peripheral blood leukocyte count is less than 3.0 x 109/l, the blood granulocyte count is less than 1.5 x 109/l, or the blood thrombocyte count is less than 120 x 109/l
boolean
C0023508 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Physical illness Preventing Chemotherapy | Mental disorders Preventing Chemotherapy
Item
any physical or mental disorder that is considered to prohibit administration of chemotherapy
boolean
C0683323 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Heart failure | Cardiac Arrhythmia Severe | Pharmaceutical Preparations Regular Required
Item
cardiac failure; severe cardiac arrythmia requiring regular medication
boolean
C0018801 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
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