ID

38299

Beskrivning

Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk; ODM derived from: https://clinicaltrials.gov/show/NCT02210546

Länk

https://clinicaltrials.gov/show/NCT02210546

Nyckelord

Versioner (1)
  1. 2019-10-08 2019-10-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02210546

Engelsk

Eligibility Breast Cancer NCT02210546

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged 40-59 years with
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). the lifetime cumulative risk of breast cancer will be computed using the ibis breast cancer risk evaluation tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. the evaluation of the composition of the mammary gland will be performed using the bi-rads classification. women with mammography in class 4 (i.e., >75% of glandular component) will be eligible for randomization.
Beskrivning

Risk Cumulative Breast Carcinoma | Lifetime Risk Cumulative Breast Carcinoma | Tyrer-Cuzick Model | Mammographic Breast Density Mammography | BI-RADS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C1511559
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C4071830
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1511559
UMLS CUI [2,4]
C0678222
UMLS CUI [3]
C2984557
UMLS CUI [4,1]
C1268717
UMLS CUI [4,2]
C0024671
UMLS CUI [5]
C1511314
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
signs or symptoms of breast cancer at enrolment;
Beskrivning

Sign or Symptom Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0678222
previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
Beskrivning

DCIS | Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0853879
brca or p53 mutation carrier status;
Beskrivning

BRCA gene Mutation Carrier | p53 gene Mutation Carrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C2985478
UMLS CUI [2,1]
C0079419
UMLS CUI [2,2]
C2985478
general contraindications to mri (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
Beskrivning

Medical contraindication MRI | Artificial cardiac pacemaker | Metallic implant | Severe allergic reaction | Status post Administration Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C3693688
UMLS CUI [4]
C2220378
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1533734
UMLS CUI [5,3]
C0009924
contraindications to any intravenous administration of contrast agent;
Beskrivning

Medical contraindication Intravenous administration Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013125
UMLS CUI [1,3]
C0009924
ongoing or planned pregnancy (for the duration of the study);
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
Beskrivning

Enhancement Hormonal Ovarian function | Reproduction Assisted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349975
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C0678879
UMLS CUI [2,1]
C0035150
UMLS CUI [2,2]
C1269765
presence of breast implants;
Beskrivning

Breast implants

Datatyp

boolean

Alias
UMLS CUI [1]
C0179412
previous diagnosis of cancer at any site;
Beskrivning

Malignant Neoplasm Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
life-threatening diseases;
Beskrivning

Life threatening illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3846017
mental disability precluding informed consent to participate
Beskrivning

Mental handicap Excludes Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
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Similar models

Eligibility Breast Cancer NCT02210546

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged 40-59 years with
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Risk Cumulative Breast Carcinoma | Lifetime Risk Cumulative Breast Carcinoma | Tyrer-Cuzick Model | Mammographic Breast Density Mammography | BI-RADS
Item
cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). the lifetime cumulative risk of breast cancer will be computed using the ibis breast cancer risk evaluation tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. the evaluation of the composition of the mammary gland will be performed using the bi-rads classification. women with mammography in class 4 (i.e., >75% of glandular component) will be eligible for randomization.
boolean
C0035647 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C4071830 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1511559 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
C2984557 (UMLS CUI [3])
C1268717 (UMLS CUI [4,1])
C0024671 (UMLS CUI [4,2])
C1511314 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sign or Symptom Breast Carcinoma
Item
signs or symptoms of breast cancer at enrolment;
boolean
C3540840 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
DCIS | Invasive carcinoma of breast
Item
previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
BRCA gene Mutation Carrier | p53 gene Mutation Carrier
Item
brca or p53 mutation carrier status;
boolean
C0596223 (UMLS CUI [1,1])
C2985478 (UMLS CUI [1,2])
C0079419 (UMLS CUI [2,1])
C2985478 (UMLS CUI [2,2])
Medical contraindication MRI | Artificial cardiac pacemaker | Metallic implant | Severe allergic reaction | Status post Administration Contrast Media
Item
general contraindications to mri (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C2220378 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C1533734 (UMLS CUI [5,2])
C0009924 (UMLS CUI [5,3])
Medical contraindication Intravenous administration Contrast Media
Item
contraindications to any intravenous administration of contrast agent;
boolean
C1301624 (UMLS CUI [1,1])
C0013125 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
ongoing or planned pregnancy (for the duration of the study);
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Enhancement Hormonal Ovarian function | Reproduction Assisted
Item
hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
boolean
C2349975 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0678879 (UMLS CUI [1,3])
C0035150 (UMLS CUI [2,1])
C1269765 (UMLS CUI [2,2])
Breast implants
Item
presence of breast implants;
boolean
C0179412 (UMLS CUI [1])
Malignant Neoplasm Previous
Item
previous diagnosis of cancer at any site;
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Life threatening illness
Item
life-threatening diseases;
boolean
C3846017 (UMLS CUI [1])
Mental handicap Excludes Informed Consent
Item
mental disability precluding informed consent to participate
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
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