ID

38131

Description

FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01864083

Link

https://clinicaltrials.gov/show/NCT01864083

Keywords

  1. 9/20/19 9/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT01864083

Eligibility Breast Cancer NCT01864083

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women presenting for evaluation at mskcc with biopsy proven primary idc or ilc
Description

Gender | Invasive Ductal Breast Carcinoma Biopsy | Invasive Lobular Breast Carcinoma Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0279565
UMLS CUI [3,2]
C0005558
no prior therapy for idc or ilc
Description

Prior Therapy Absent Invasive Ductal Breast Carcinoma | Prior Therapy Absent Invasive Lobular Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1134719
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0279565
clinical need for local disease staging with breast mr (group a only)
Description

Local disease TNM Breast tumor staging | Magnetic resonance imaging of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0344104
clinical need for neoadjuvant chemotherapy (group b only)
Description

Patient need for Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C3665472
patients must provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
men
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have already started treatment for the current malignancy
Description

Therapeutic procedure Started Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1272689
UMLS CUI [1,3]
C0006826
patients who cannot undergo pet scanning (i.e. because of weight limits)
Description

PET scan Unsuccessful | Etiology Body Weight Limit

Data type

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0005910
UMLS CUI [2,3]
C0439801
patients who are known to have contraindication for mri (e.g. metal implants)
Description

Medical contraindication MRI | Presence of metallic implant

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3693688
patients may only participate in group #1 or group #2, but not both
Description

Study Subject Participation Status | Group Singular

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0205171

Similar models

Eligibility Breast Cancer NCT01864083

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive Ductal Breast Carcinoma Biopsy | Invasive Lobular Breast Carcinoma Biopsy
Item
women presenting for evaluation at mskcc with biopsy proven primary idc or ilc
boolean
C0079399 (UMLS CUI [1])
C1134719 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0279565 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Prior Therapy Absent Invasive Ductal Breast Carcinoma | Prior Therapy Absent Invasive Lobular Breast Carcinoma
Item
no prior therapy for idc or ilc
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1134719 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279565 (UMLS CUI [2,3])
Local disease TNM Breast tumor staging | Magnetic resonance imaging of breast
Item
clinical need for local disease staging with breast mr (group a only)
boolean
C0277565 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0344104 (UMLS CUI [2])
Patient need for Neoadjuvant Chemotherapy
Item
clinical need for neoadjuvant chemotherapy (group b only)
boolean
C0686904 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
Informed Consent
Item
patients must provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <21 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
men
boolean
C0079399 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Started Malignant Neoplasms
Item
patients who have already started treatment for the current malignancy
boolean
C0087111 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
PET scan Unsuccessful | Etiology Body Weight Limit
Item
patients who cannot undergo pet scanning (i.e. because of weight limits)
boolean
C0032743 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0005910 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Medical contraindication MRI | Presence of metallic implant
Item
patients who are known to have contraindication for mri (e.g. metal implants)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
Study Subject Participation Status | Group Singular
Item
patients may only participate in group #1 or group #2, but not both
boolean
C2348568 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial