ID

37819

Description

Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01051609

Link

https://clinicaltrials.gov/show/NCT01051609

Keywords

Versions (1)
  1. 8/26/19 8/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01051609

English

Eligibility Breast Cancer NCT01051609

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years and older with non-metastatic hormone receptor (er and/or pr) positive breast cancer who are eligible for and planning on starting treatment with an ai within one month of signing consent.
Description

Gender | Age | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Aromatase Inhibitors Planned

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C2938924
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0279759
UMLS CUI [5,1]
C0593802
UMLS CUI [5,2]
C1301732
postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.
Description

Postmenopausal state | Amenorrhea Duration | Bilateral oophorectomy Previous

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
Description

Connective Tissue Diseases Autoimmune | Rheumatoid Arthritis | Lupus Erythematosus | Autoimmune Diseases Affecting Joints

Data type

boolean

Alias
UMLS CUI [1,1]
C0009782
UMLS CUI [1,2]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0409974
UMLS CUI [4,1]
C0004364
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0022417
treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
Description

Steroid therapy Condition Any | Exception Chemotherapy Premedication

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0033045
prior treatment with an ai (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
Description

Aromatase Inhibitors Previous | Tamoxifen | Tamoxifen To be stopped Before Blood draw

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0039286
UMLS CUI [3,1]
C0039286
UMLS CUI [3,2]
C1272691
UMLS CUI [3,3]
C0332152
UMLS CUI [3,4]
C0005834
active or ongoing infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
known metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
known history of hiv or hepatitis infections
Description

HIV Infection | Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an ai)
Description

Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
non-invasive (dcis, lcis) cancer only (no diagnosis of invasive cancer)
Description

Malignant neoplasm of breast Non-invasive | Noninfiltrating Intraductal Carcinoma | Lobular carcinoma in situ of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0205303
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0279563
pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to speak, read, and write in english
Description

Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0584993
UMLS CUI [3,3]
C0376245
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Similar models

Eligibility Breast Cancer NCT01051609

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Aromatase Inhibitors Planned
Item
women 18 years and older with non-metastatic hormone receptor (er and/or pr) positive breast cancer who are eligible for and planning on starting treatment with an ai within one month of signing consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2938924 (UMLS CUI [3])
C0678222 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
C0593802 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
Postmenopausal state | Amenorrhea Duration | Bilateral oophorectomy Previous
Item
postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Connective Tissue Diseases Autoimmune | Rheumatoid Arthritis | Lupus Erythematosus | Autoimmune Diseases Affecting Joints
Item
history of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
boolean
C0009782 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0004364 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0022417 (UMLS CUI [4,3])
Steroid therapy Condition Any | Exception Chemotherapy Premedication
Item
treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
boolean
C0149783 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0033045 (UMLS CUI [2,3])
Aromatase Inhibitors Previous | Tamoxifen | Tamoxifen To be stopped Before Blood draw
Item
prior treatment with an ai (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
boolean
C0593802 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
C0039286 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0005834 (UMLS CUI [3,4])
Communicable Disease
Item
active or ongoing infection
boolean
C0009450 (UMLS CUI [1])
Neoplasm Metastasis
Item
known metastatic disease
boolean
C0027627 (UMLS CUI [1])
HIV Infection | Hepatitis
Item
known history of hiv or hepatitis infections
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
Therapeutic radiology procedure Completed
Item
ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an ai)
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Malignant neoplasm of breast Non-invasive | Noninfiltrating Intraductal Carcinoma | Lobular carcinoma in situ of breast
Item
non-invasive (dcis, lcis) cancer only (no diagnosis of invasive cancer)
boolean
C0006142 (UMLS CUI [1,1])
C0205303 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language
Item
unable to speak, read, and write in english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
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