ID

13697

Description

Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid; ODM derived from: https://clinicaltrials.gov/show/NCT01409811

Link

https://clinicaltrials.gov/show/NCT01409811

Keywords

  1. 2/28/16 2/28/16 -
Uploaded on

February 28, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Estrogen Receptor-positive Breast Cancer NCT01409811

Eligibility Estrogen Receptor-positive Breast Cancer NCT01409811

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women
Description

postmenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0232970
diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
Description

invasive ductal carcinoma; lumpectomy; mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0851238
UMLS CUI [3]
C0024881
estrogen receptor (er)/progesterone receptor (pr) positive tumor (as confirmed by city of hope pathology department if done on the outside) or
Description

Estrogen receptor positive tumor; Progesterone receptor positive tumor

Data type

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2]
C1562928
biopsy proven er/pr positive tumor
Description

biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0005558
ability to provide informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor that lacks both estrogen and progesterone receptors
Description

progesterone receptor; estrogen receptor

Data type

boolean

Alias
UMLS CUI [1]
C2919590
UMLS CUI [2]
C0034804
patients who will receive neoadjuvant therapy prior to definitive surgery
Description

neoadjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0600558
bisphosphonate therapy currently or within the past 12 months
Description

therapy bisphosphonate

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0012544
regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (pi's) discretion
Description

anti-inflammatory agents; baby aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2]
C3843720
renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the cockcroft-gault formula using the patient's actual weight
Description

cockcroft-gault formula; creatinine clearance; Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C2924627
UMLS CUI [2]
C0812399
UMLS CUI [3]
C1565489
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures
Description

comorbidity dental

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0226984
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Description

dental surgery; extraction; implants

Data type

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0185115
UMLS CUI [3]
C0021102

Similar models

Eligibility Estrogen Receptor-positive Breast Cancer NCT01409811

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
postmenopausal
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
invasive ductal carcinoma; lumpectomy; mastectomy
Item
diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
boolean
C1134719 (UMLS CUI [1])
C0851238 (UMLS CUI [2])
C0024881 (UMLS CUI [3])
Estrogen receptor positive tumor; Progesterone receptor positive tumor
Item
estrogen receptor (er)/progesterone receptor (pr) positive tumor (as confirmed by city of hope pathology department if done on the outside) or
boolean
C1562312 (UMLS CUI [1])
C1562928 (UMLS CUI [2])
biopsy
Item
biopsy proven er/pr positive tumor
boolean
C0005558 (UMLS CUI [1])
informed consent
Item
ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
progesterone receptor; estrogen receptor
Item
tumor that lacks both estrogen and progesterone receptors
boolean
C2919590 (UMLS CUI [1])
C0034804 (UMLS CUI [2])
neoadjuvant therapy
Item
patients who will receive neoadjuvant therapy prior to definitive surgery
boolean
C0600558 (UMLS CUI [1])
therapy bisphosphonate
Item
bisphosphonate therapy currently or within the past 12 months
boolean
C0087111 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
anti-inflammatory agents; baby aspirin
Item
regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (pi's) discretion
boolean
C0003209 (UMLS CUI [1])
C3843720 (UMLS CUI [2])
cockcroft-gault formula; creatinine clearance; Renal Insufficiency
Item
renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the cockcroft-gault formula using the patient's actual weight
boolean
C2924627 (UMLS CUI [1])
C0812399 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
comorbidity dental
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures
boolean
C0009488 (UMLS CUI [1,1])
C0226984 (UMLS CUI [1,2])
dental surgery; extraction; implants
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
boolean
C0204324 (UMLS CUI [1])
C0185115 (UMLS CUI [2])
C0021102 (UMLS CUI [3])

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