ID

37779

Description

Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms; ODM derived from: https://clinicaltrials.gov/show/NCT01075802

Link

https://clinicaltrials.gov/show/NCT01075802

Keywords

  1. 8/24/19 8/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 24, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01075802

Eligibility Breast Cancer NCT01075802

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥ 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
histologically or cytologically confirmed early, locally advanced or metastatic breast cancer
Description

Early-Stage Breast Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C2986665
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
oestrogen receptor positive
Description

Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
about to start tamoxifen treatment or already on tamoxifen 20mg daily
Description

Tamoxifen Medication started | Tamoxifen U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C0451613
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C0456683
adequate hepatic and renal function
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent chemotherapy or radiotherapy
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
treatment with medications that may alter cytochrome p450 (cyp450)3a4/5 and cyp2d6 activities
Description

Pharmaceutical Preparations Changing CYP3A4 Activity | Pharmaceutical Preparations Changing CYP3A5 Activity | Pharmaceutical Preparations Changing CYP2D6 Activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C3714798
UMLS CUI [1,4]
C0205177
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C3714750
UMLS CUI [2,4]
C0205177
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0057223
UMLS CUI [3,4]
C0205177
history of thrombosis
Description

Thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0040053
history of non-compliance with previous or current treatment;
Description

Treatment Compliance Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332197
medical or psychiatric conditions that compromise the patient's ability to give informed consent
Description

Medical condition compromises Informed Consent | Mental condition compromises Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0021430

Similar models

Eligibility Breast Cancer NCT01075802

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Early-Stage Breast Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
histologically or cytologically confirmed early, locally advanced or metastatic breast cancer
boolean
C2986665 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Estrogen receptor positive
Item
oestrogen receptor positive
boolean
C0279754 (UMLS CUI [1])
Tamoxifen Medication started | Tamoxifen U/day
Item
about to start tamoxifen treatment or already on tamoxifen 20mg daily
boolean
C0039286 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Liver function | Renal function
Item
adequate hepatic and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
concurrent chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Pharmaceutical Preparations Changing CYP3A4 Activity | Pharmaceutical Preparations Changing CYP3A5 Activity | Pharmaceutical Preparations Changing CYP2D6 Activity
Item
treatment with medications that may alter cytochrome p450 (cyp450)3a4/5 and cyp2d6 activities
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C3714750 (UMLS CUI [2,3])
C0205177 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0057223 (UMLS CUI [3,3])
C0205177 (UMLS CUI [3,4])
Thrombosis
Item
history of thrombosis
boolean
C0040053 (UMLS CUI [1])
Treatment Compliance Absent
Item
history of non-compliance with previous or current treatment;
boolean
C4319828 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medical condition compromises Informed Consent | Mental condition compromises Informed Consent
Item
medical or psychiatric conditions that compromise the patient's ability to give informed consent
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])

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