ID

38300

Beschrijving

FAST MRI Study in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02244593

Link

https://clinicaltrials.gov/show/NCT02244593

Trefwoorden

Versies (1)
  1. 08-10-19 08-10-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02244593

Engels

Eligibility Breast Cancer NCT02244593

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
english or french speaking female patients over the age of 18 years, with a personal history of a diagnosis of breast carcinoma (including ductal carcinoma in situ (dcis) and invasive ductal or lobular carcinoma) within the past 10 years.
Beschrijving

Able to speak English Language | Able to speak French language | Gender | Age | Breast Carcinoma | DCIS | Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376246
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0678222
UMLS CUI [6]
C0007124
UMLS CUI [7]
C1134719
UMLS CUI [8]
C0279565
patients must have completed treatment for their breast cancer.
Beschrijving

Treatment completed Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0678222
moderate risk for recurrence of breast cancer, defined as lifetime risk of breast cancer greater than 12% (average risk) and less than 25% (high risk) as defined using the breast and ovarian analysis of disease incidence and carrier estimation algorithm (boadicea) model (see appendix a)
Beschrijving

Moderate risk of Breast cancer recurrent | Lifetime Risk Percentage Breast Carcinoma | Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332166
UMLS CUI [1,2]
C0278493
UMLS CUI [2,1]
C1517878
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0678222
UMLS CUI [3]
C2984558
patients who have undergone unilateral mastectomy or breast conservation surgery.
Beschrijving

Simple mastectomy | Breast-Conserving Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2]
C0917927
normal renal function: estimated glomerular filtration rate (egfr) > 30 ml/min/m2
Beschrijving

Renal function | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C3811844
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients unable to undergo an mri, due to either physical or mental issues (i.e.: anxiety or severe claustrophobia). also, patient with a known allergy to gadolinium, or severe renal failure will be excluded.
Beschrijving

MRI Receive Unable | Etiology Problem Physical | Etiology Mental problem | Anxiety | Claustrophobia Severe | Hypersensitivity Gadolinium | Kidney Failure Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0033213
UMLS CUI [2,3]
C0205485
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0848067
UMLS CUI [4]
C0003467
UMLS CUI [5,1]
C0008909
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0016911
UMLS CUI [7,1]
C0035078
UMLS CUI [7,2]
C0205082
pregnant or breastfeeding patients.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have had a breast mri within the last 6 months.
Beschrijving

Magnetic resonance imaging of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0344104
patients already receiving high-risk breast mri screening, such as the ontario breast screening program (obsp) high-risk program and the women's breast health center (wbhc) high-risk program.
Beschrijving

High risk MRI of breast Screening

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0344104
UMLS CUI [1,3]
C1710032
patients who have undergone bilateral mastectomies.
Beschrijving

Bilateral mastectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0191877
poor renal function: estimated glomerular filtration rate (egfr) < 30 ml/min/m2
Beschrijving

Renal function Poor | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C3811844
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Similar models

Eligibility Breast Cancer NCT02244593

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language | Able to speak French language | Gender | Age | Breast Carcinoma | DCIS | Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma
Item
english or french speaking female patients over the age of 18 years, with a personal history of a diagnosis of breast carcinoma (including ductal carcinoma in situ (dcis) and invasive ductal or lobular carcinoma) within the past 10 years.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0678222 (UMLS CUI [5])
C0007124 (UMLS CUI [6])
C1134719 (UMLS CUI [7])
C0279565 (UMLS CUI [8])
Treatment completed Breast Carcinoma
Item
patients must have completed treatment for their breast cancer.
boolean
C0580352 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Moderate risk of Breast cancer recurrent | Lifetime Risk Percentage Breast Carcinoma | Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm
Item
moderate risk for recurrence of breast cancer, defined as lifetime risk of breast cancer greater than 12% (average risk) and less than 25% (high risk) as defined using the breast and ovarian analysis of disease incidence and carrier estimation algorithm (boadicea) model (see appendix a)
boolean
C0332166 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C1517878 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C2984558 (UMLS CUI [3])
Simple mastectomy | Breast-Conserving Surgery
Item
patients who have undergone unilateral mastectomy or breast conservation surgery.
boolean
C0024886 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
Renal function | Estimated Glomerular Filtration Rate
Item
normal renal function: estimated glomerular filtration rate (egfr) > 30 ml/min/m2
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
MRI Receive Unable | Etiology Problem Physical | Etiology Mental problem | Anxiety | Claustrophobia Severe | Hypersensitivity Gadolinium | Kidney Failure Severe
Item
patients unable to undergo an mri, due to either physical or mental issues (i.e.: anxiety or severe claustrophobia). also, patient with a known allergy to gadolinium, or severe renal failure will be excluded.
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0033213 (UMLS CUI [2,2])
C0205485 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0848067 (UMLS CUI [3,2])
C0003467 (UMLS CUI [4])
C0008909 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0016911 (UMLS CUI [6,2])
C0035078 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Magnetic resonance imaging of breast
Item
patients who have had a breast mri within the last 6 months.
boolean
C0344104 (UMLS CUI [1])
High risk MRI of breast Screening
Item
patients already receiving high-risk breast mri screening, such as the ontario breast screening program (obsp) high-risk program and the women's breast health center (wbhc) high-risk program.
boolean
C4319571 (UMLS CUI [1,1])
C0344104 (UMLS CUI [1,2])
C1710032 (UMLS CUI [1,3])
Bilateral mastectomy
Item
patients who have undergone bilateral mastectomies.
boolean
C0191877 (UMLS CUI [1])
Renal function Poor | Estimated Glomerular Filtration Rate
Item
poor renal function: estimated glomerular filtration rate (egfr) < 30 ml/min/m2
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
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