ID

37714

Description

18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02110160

Link

https://clinicaltrials.gov/show/NCT02110160

Keywords

Versions (1)
  1. 8/19/19 8/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Bone Dominant Metastatic ER+ Breast Cancer NCT02110160

English

Eligibility Bone Dominant Metastatic ER+ Breast Cancer NCT02110160

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, at least 18 years of age, with a history of pathologically confirmed er+ breast cancer
Description

Adult | Age | Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C2938924
biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
Description

Secondary malignant neoplasm of bone From Breast Carcinoma | Secondary malignant neoplasm of bone Predominant

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1517320
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C1542147
patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
Description

Endocrine Therapy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1301732
willing and able to comply with scheduled visits and serial imaging procedures
Description

Compliance Visits Scheduled | Compliance Imaging Procedures Repeated

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C0205341
agrees to allow access to clinical records regarding response to treatment and long term follow up 6. be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines.
Description

Access Medical Records allowing | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0025102
UMLS CUI [1,3]
C0683607
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dl)
Description

DIABETES MELLITUS UNCONTROLLED | Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0743131
UMLS CUI [2]
C0202045
inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
Description

Imaging procedures Receive Unable | Claustrophobia | Severe pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0079595
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0008909
UMLS CUI [3]
C0278140
weight exceeding capacity of imaging table
Description

Body Weight Inappropriate Imaging procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0079595
previous treatment with radiation or surgery to a significant percentage of bony metastatic sites 6. treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (gcsf)) within 3 weeks of baseline scan
Description

Prior radiation therapy Metastatic cancer site Bony | Operative Surgical Procedure Metastatic cancer site Bony | Pharmaceutical Preparations Bone Marrow Stimulation | Granulocyte Colony-Stimulating Factor

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0280457
UMLS CUI [1,3]
C0443157
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0280457
UMLS CUI [2,3]
C0443157
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0005953
UMLS CUI [3,3]
C1292856
UMLS CUI [4]
C0079459
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Similar models

Eligibility Bone Dominant Metastatic ER+ Breast Cancer NCT02110160

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Oestrogen receptor positive breast cancer
Item
adult patients, at least 18 years of age, with a history of pathologically confirmed er+ breast cancer
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2938924 (UMLS CUI [3])
Secondary malignant neoplasm of bone From Breast Carcinoma | Secondary malignant neoplasm of bone Predominant
Item
biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
boolean
C0153690 (UMLS CUI [1,1])
C1517320 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0153690 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
Endocrine Therapy Planned
Item
patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
boolean
C0279025 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Compliance Visits Scheduled | Compliance Imaging Procedures Repeated
Item
willing and able to comply with scheduled visits and serial imaging procedures
boolean
C1321605 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Access Medical Records allowing | Informed Consent
Item
agrees to allow access to clinical records regarding response to treatment and long term follow up 6. be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines.
boolean
C0444454 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
DIABETES MELLITUS UNCONTROLLED | Glucose measurement, fasting
Item
uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dl)
boolean
C0743131 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
Imaging procedures Receive Unable | Claustrophobia | Severe pain
Item
inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
boolean
C0079595 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
C0278140 (UMLS CUI [3])
Body Weight Inappropriate Imaging procedure
Item
weight exceeding capacity of imaging table
boolean
C0005910 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0079595 (UMLS CUI [1,3])
Prior radiation therapy Metastatic cancer site Bony | Operative Surgical Procedure Metastatic cancer site Bony | Pharmaceutical Preparations Bone Marrow Stimulation | Granulocyte Colony-Stimulating Factor
Item
previous treatment with radiation or surgery to a significant percentage of bony metastatic sites 6. treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (gcsf)) within 3 weeks of baseline scan
boolean
C0279134 (UMLS CUI [1,1])
C0280457 (UMLS CUI [1,2])
C0443157 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0280457 (UMLS CUI [2,2])
C0443157 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C1292856 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4])
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