ID

33899

Description

Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01975597

Link

https://clinicaltrials.gov/show/NCT01975597

Keywords

  1. 1/6/19 1/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 6, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT01975597

Eligibility Metastatic Breast Cancer NCT01975597

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with metastatic breast cancer (any site) age 21 or older
Description

Secondary malignant neoplasm of female breast | Age

Data type

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0001779
patients willing and able to provide informed consent & perform study procedures
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
patients may enroll with stable, responding or progressive tumor burden
Description

Tumor Burden Stable | Tumor Burden Response | Tumor Burden Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1449699
UMLS CUI [2,2]
C1704632
UMLS CUI [3,1]
C1449699
UMLS CUI [3,2]
C0205329
performance status of 0,1 or 2
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients unable or unwilling to provide informed consent and or perform study procedures
Description

Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
patients with active, uncontrolled coagulopathy
Description

Blood Coagulation Disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205318
patients on treatment dose anticoagulation or an international normalised ratio of 2 or greater if on warfarin
Description

Anticoagulation Therapy Dose | International Normalized Ratio | Relationship Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C0525032
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0043031
patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Metastatic Breast Cancer NCT01975597

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Age
Item
patients with metastatic breast cancer (any site) age 21 or older
boolean
C0346993 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
patients willing and able to provide informed consent & perform study procedures
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Tumor Burden Stable | Tumor Burden Response | Tumor Burden Progressive
Item
patients may enroll with stable, responding or progressive tumor burden
boolean
C1449699 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1449699 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C1449699 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
Performance status
Item
performance status of 0,1 or 2
boolean
C1518965 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling
Item
patients unable or unwilling to provide informed consent and or perform study procedures
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Blood Coagulation Disorder Uncontrolled
Item
patients with active, uncontrolled coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Anticoagulation Therapy Dose | International Normalized Ratio | Relationship Warfarin
Item
patients on treatment dose anticoagulation or an international normalised ratio of 2 or greater if on warfarin
boolean
C0003281 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
Pregnancy
Item
patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy
boolean
C0032961 (UMLS CUI [1])

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