ID

35092

Descrição

MRI and Early Decision-making in Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02449824

Link

https://clinicaltrials.gov/show/NCT02449824

Palavras-chave

Versões (1)
  1. 15/02/2019 15/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02449824

Inglês

Eligibility Breast Neoplasms NCT02449824

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed large but operable invasive carcinoma of the breast. all molecular subtypes are eligible and incidentally detected small volume metastatic disease is not an exclusion criterion.
Descrição

Invasive carcinoma of breast Large Operable | Subtype Molecular All | Neoplasm Metastasis Volume Small

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C0205188
UMLS CUI [2,1]
C0449560
UMLS CUI [2,2]
C1521991
UMLS CUI [2,3]
C0444868
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0449468
UMLS CUI [3,3]
C0700321
clinical indication for nac as determined by the breast therapeutic mdt.
Descrição

Indication Chemotherapy Neoadjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1298676
sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
Descrição

Biopsy Material Sufficient | Biological Markers Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0520510
UMLS CUI [1,3]
C0205410
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0242485
participant is willing and able to give informed consent for participation in the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
female, aged 18 years or above.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
Descrição

Invasive carcinoma of breast | Prior Therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
Descrição

Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0700589
participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min).
Descrição

Renal function | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C3811844
in the investigator's opinion, is able and willing to comply with all study requirements.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
Descrição

Therapeutic radiology procedure Breast Carcinoma Previous | Chemotherapy Breast Carcinoma Previous | Breast cancer recurrent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0205156
UMLS CUI [3]
C0278493
female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
Descrição

Renal Insufficiency | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
contraindication to mri.
Descrição

Medical contraindication MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
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Similar models

Eligibility Breast Neoplasms NCT02449824

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Large Operable | Subtype Molecular All | Neoplasm Metastasis Volume Small
Item
newly diagnosed large but operable invasive carcinoma of the breast. all molecular subtypes are eligible and incidentally detected small volume metastatic disease is not an exclusion criterion.
boolean
C0853879 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C0449560 (UMLS CUI [2,1])
C1521991 (UMLS CUI [2,2])
C0444868 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0449468 (UMLS CUI [3,2])
C0700321 (UMLS CUI [3,3])
Indication Chemotherapy Neoadjuvant
Item
clinical indication for nac as determined by the breast therapeutic mdt.
boolean
C3146298 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1298676 (UMLS CUI [1,3])
Biopsy Material Sufficient | Biological Markers Measurement
Item
sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
boolean
C0005558 (UMLS CUI [1,1])
C0520510 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
Informed Consent
Item
participant is willing and able to give informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
female, aged 18 years or above.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast | Prior Therapy Absent
Item
histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
boolean
C0853879 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods
Item
female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Renal function | Estimated Glomerular Filtration Rate
Item
participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min).
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Protocol Compliance
Item
in the investigator's opinion, is able and willing to comply with all study requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Breast Carcinoma Previous | Chemotherapy Breast Carcinoma Previous | Breast cancer recurrent
Item
previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0278493 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female participant who is pregnant, lactating or planning pregnancy during the course of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Medical contraindication MRI
Item
contraindication to mri.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
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