ID

38193

Description

Bone Metastasis and Surgery in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02125630

Link

https://clinicaltrials.gov/show/NCT02125630

Keywords

Versions (1)
  1. 9/25/19 9/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02125630

English

Eligibility Breast Cancer NCT02125630

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary breast tumor amenable for complete surgical resection
Description

Breast Carcinoma Amenable Complete excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0015250
patients in good physical condition for receiving protocol driven locoregional and systemic treatment
Description

Individual Physical Condition Good | Patient Fit Therapy Locoregional | Patient Fit Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C0205170
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0424576
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1947913
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0424576
UMLS CUI [3,3]
C1515119
patients eligible for sentinel lymph node (sln) biopsy and receiving radiotherapy.
Description

Patient Eligible Sentinel Lymph Node Biopsy | Patient Eligible Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0796693
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C1522449
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; t4a,c or inflammatory breast cancer; t4d)
Description

Primary tumor Inappropriate Complete excision | Primary tumor TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0015250
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0474926
primary tumor with extended infection, bleeding, or necrosis
Description

Primary tumor With Communicable Disease Extended | Primary tumor With Hemorrhage | Primary tumor With Necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0009450
UMLS CUI [1,4]
C0231449
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0019080
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0027540
patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
Description

Poor physical condition Preventing Therapy Locoregional | Poor physical condition Preventing Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2111874
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1947913
UMLS CUI [2,1]
C2111874
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1515119
synchronous primary cancer at the contralateral breast
Description

Primary tumor Synchronous Breast Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0439580
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0441988
previous diagnosis of other cancers (excluding basal cell skin cancer
Description

Cancer Other | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
squamous cell skin cancer
Description

Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0553723
cervical intraepithelial neoplasia)
Description

Exception Cervical Intraepithelial Neoplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0206708
clinically involved contralateral axillary nodes
Description

Involvement with Axillary lymph nodes Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C0441988
patients not suitable for adequate follow-up
Description

Patients Inappropriate Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C3274571
failure to give informed consent
Description

Informed Consent failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Breast Cancer NCT02125630

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Amenable Complete excision
Item
primary breast tumor amenable for complete surgical resection
boolean
C0678222 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0015250 (UMLS CUI [1,3])
Individual Physical Condition Good | Patient Fit Therapy Locoregional | Patient Fit Systemic therapy
Item
patients in good physical condition for receiving protocol driven locoregional and systemic treatment
boolean
C3714565 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0424576 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1947913 (UMLS CUI [2,4])
C0030705 (UMLS CUI [3,1])
C0424576 (UMLS CUI [3,2])
C1515119 (UMLS CUI [3,3])
Patient Eligible Sentinel Lymph Node Biopsy | Patient Eligible Therapeutic radiology procedure
Item
patients eligible for sentinel lymph node (sln) biopsy and receiving radiotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Primary tumor Inappropriate Complete excision | Primary tumor TNM Breast tumor staging
Item
primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; t4a,c or inflammatory breast cancer; t4d)
boolean
C0677930 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0015250 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
Primary tumor With Communicable Disease Extended | Primary tumor With Hemorrhage | Primary tumor With Necrosis
Item
primary tumor with extended infection, bleeding, or necrosis
boolean
C0677930 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0231449 (UMLS CUI [1,4])
C0677930 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0027540 (UMLS CUI [3,3])
Poor physical condition Preventing Therapy Locoregional | Poor physical condition Preventing Systemic therapy
Item
patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
boolean
C2111874 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1947913 (UMLS CUI [1,4])
C2111874 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,3])
Primary tumor Synchronous Breast Contralateral
Item
synchronous primary cancer at the contralateral breast
boolean
C0677930 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0441988 (UMLS CUI [1,4])
Cancer Other | Exception Basal cell carcinoma
Item
previous diagnosis of other cancers (excluding basal cell skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Exception Squamous cell carcinoma of skin
Item
squamous cell skin cancer
boolean
C1705847 (UMLS CUI [1,1])
C0553723 (UMLS CUI [1,2])
Exception Cervical Intraepithelial Neoplasia
Item
cervical intraepithelial neoplasia)
boolean
C1705847 (UMLS CUI [1,1])
C0206708 (UMLS CUI [1,2])
Involvement with Axillary lymph nodes Contralateral
Item
clinically involved contralateral axillary nodes
boolean
C1314939 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
Patients Inappropriate Follow-up
Item
patients not suitable for adequate follow-up
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Informed Consent failed
Item
failure to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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