ID

38218

Beschrijving

Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02488187

Link

https://clinicaltrials.gov/show/NCT02488187

Trefwoorden

  1. 28-09-19 28-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 september 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02488187

Eligibility Breast Cancer NCT02488187

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women (age 18-100) undergoing preoperative evaluation at the university of kansas cancer center (kucc) for a new diagnosis of breast cancer
Beschrijving

Gender | Age | Pre-surgery evaluation New Diagnosis Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1293091
UMLS CUI [3,2]
C1882082
UMLS CUI [3,3]
C0678222
patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
Beschrijving

Breast Carcinoma Core needle biopsy | Breast Carcinoma Excision biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0184921
bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the mri and abus.
Beschrijving

Indication Bilateral mammography | Indication Hand-held-transducer ultrasonography

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0203027
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0524315
if a breast mri is advised and there is no contraindication to mri, a breast mri and abus will performed at kucc (study arm 1).
Beschrijving

Patient advised to MRI of breast | Medical contraindication Absent MRI | MRI of breast | Mammary Ultrasonography Automated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0418832
UMLS CUI [1,2]
C0344104
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0024485
UMLS CUI [3]
C0344104
UMLS CUI [4,1]
C0080264
UMLS CUI [4,2]
C0205554
if a breast mri is not performed, an abus exam without mri will be performed (study arm 2).
Beschrijving

MRI Absent | Mammary Ultrasonography Automated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0080264
UMLS CUI [2,2]
C0205554
the mri and abus exam must be obtained within 2 weeks of each other.
Beschrijving

MRI | Mammary Ultrasonography Automated | Time Interval

Datatype

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2,1]
C0080264
UMLS CUI [2,2]
C0205554
UMLS CUI [3]
C0872291
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
males
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
pregnant women
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
lactating women
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
patients < 18 and > 100 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with breast implants
Beschrijving

Breast implants

Datatype

boolean

Alias
UMLS CUI [1]
C0179412

Similar models

Eligibility Breast Cancer NCT02488187

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Pre-surgery evaluation New Diagnosis Breast Carcinoma
Item
women (age 18-100) undergoing preoperative evaluation at the university of kansas cancer center (kucc) for a new diagnosis of breast cancer
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1293091 (UMLS CUI [3,1])
C1882082 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
Breast Carcinoma Core needle biopsy | Breast Carcinoma Excision biopsy
Item
patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
boolean
C0678222 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0184921 (UMLS CUI [2,2])
Indication Bilateral mammography | Indication Hand-held-transducer ultrasonography
Item
bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the mri and abus.
boolean
C3146298 (UMLS CUI [1,1])
C0203027 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0524315 (UMLS CUI [2,2])
Patient advised to MRI of breast | Medical contraindication Absent MRI | MRI of breast | Mammary Ultrasonography Automated
Item
if a breast mri is advised and there is no contraindication to mri, a breast mri and abus will performed at kucc (study arm 1).
boolean
C0418832 (UMLS CUI [1,1])
C0344104 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0344104 (UMLS CUI [3])
C0080264 (UMLS CUI [4,1])
C0205554 (UMLS CUI [4,2])
MRI Absent | Mammary Ultrasonography Automated
Item
if a breast mri is not performed, an abus exam without mri will be performed (study arm 2).
boolean
C0024485 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0080264 (UMLS CUI [2,1])
C0205554 (UMLS CUI [2,2])
MRI | Mammary Ultrasonography Automated | Time Interval
Item
the mri and abus exam must be obtained within 2 weeks of each other.
boolean
C0024485 (UMLS CUI [1])
C0080264 (UMLS CUI [2,1])
C0205554 (UMLS CUI [2,2])
C0872291 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Gender
Item
males
boolean
C0079399 (UMLS CUI [1])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactating women
boolean
C0006147 (UMLS CUI [1])
Age
Item
patients < 18 and > 100 years of age
boolean
C0001779 (UMLS CUI [1])
Breast implants
Item
patients with breast implants
boolean
C0179412 (UMLS CUI [1])

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