ID

44395

Description

Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes; ODM derived from: https://clinicaltrials.gov/show/NCT00966043

Link

https://clinicaltrials.gov/show/NCT00966043

Keywords

Versions (2)
  1. 11/8/17 11/8/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00966043

English

Eligibility Breast Neoplasms NCT00966043

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female > 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
written and voluntary informed consent understood signed and dated
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
Description

Breast adenocarcinoma Invasive Measurable | Breast adenocarcinoma Amenable Curative treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1273390
patients must be postmenopausal as defined by criteria in appendix 1.
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
Description

Breast Carcinoma Estrogen receptor positive Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0021044
prior endocrine tamoxifen therapy is not allowed
Description

Exclusion Tamoxifen Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0039286
UMLS CUI [1,3]
C0279025
patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
Description

Hormone preparation Absent | Hormone replacement therapy To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0019932
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0282402
UMLS CUI [2,2]
C1272691
prior chemotherapy and radiotherapy is allowed
Description

Prior Chemotherapy | Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
adequate renal and liver function serum creatinine and serum bilirubin ≤ 1.5 x uln serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases)
Description

Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Serum alanine aminotransferase measurement | AST serum measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C1883008
UMLS CUI [6]
C1261155
UMLS CUI [7]
C0494165
serum calcium should be ≤ 11,6 mg/dl
Description

Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
ecog performance status 0,1,2 (appendix 2)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
Description

Life threatening illness Requirement Response quick | Hepatic Involvement Extensive | Pulmonary involvement Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1704632
UMLS CUI [1,4]
C0456962
UMLS CUI [2,1]
C0441932
UMLS CUI [2,2]
C0205231
UMLS CUI [3,1]
C0748159
UMLS CUI [3,2]
C0205231
use of any endocrine treatment or recent/current use of hormone replacement therapy.
Description

Hormone Therapy | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0282402
contra indication for tamoxifen: history of dvt/vaginal bleeding of unknown origin
Description

Medical contraindication Tamoxifen | Deep Vein Thrombosis | Vaginal Hemorrhage Unknown origin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0039286
UMLS CUI [2]
C0149871
UMLS CUI [3,1]
C2979982
UMLS CUI [3,2]
C0332240
dementia
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
history of other malignancy that may interfere with at least 6 months of tamoxifen therapy
Description

Cancer Other Interferes with Tamoxifen Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0039286
UMLS CUI [1,4]
C0087111
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Similar models

Eligibility Breast Neoplasms NCT00966043

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female > 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written and voluntary informed consent understood signed and dated
boolean
C0021430 (UMLS CUI [1])
Breast adenocarcinoma Invasive Measurable | Breast adenocarcinoma Amenable Curative treatment
Item
histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0858252 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
Postmenopausal state
Item
patients must be postmenopausal as defined by criteria in appendix 1.
boolean
C0232970 (UMLS CUI [1])
Breast Carcinoma Estrogen receptor positive Immunohistochemistry
Item
breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Exclusion Tamoxifen Hormone Therapy
Item
prior endocrine tamoxifen therapy is not allowed
boolean
C2828389 (UMLS CUI [1,1])
C0039286 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
Hormone preparation Absent | Hormone replacement therapy To be stopped
Item
patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
boolean
C0019932 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Prior Chemotherapy | Prior radiation therapy
Item
prior chemotherapy and radiotherapy is allowed
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Serum alanine aminotransferase measurement | AST serum measurement | Secondary malignant neoplasm of liver
Item
adequate renal and liver function serum creatinine and serum bilirubin ≤ 1.5 x uln serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases)
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1883008 (UMLS CUI [5])
C1261155 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
Serum calcium measurement
Item
serum calcium should be ≤ 11,6 mg/dl
boolean
C0728876 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0,1,2 (appendix 2)
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Life threatening illness Requirement Response quick | Hepatic Involvement Extensive | Pulmonary involvement Extensive
Item
life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
boolean
C3846017 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
C0441932 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C0748159 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
Hormone Therapy | Hormone replacement therapy
Item
use of any endocrine treatment or recent/current use of hormone replacement therapy.
boolean
C0279025 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Medical contraindication Tamoxifen | Deep Vein Thrombosis | Vaginal Hemorrhage Unknown origin
Item
contra indication for tamoxifen: history of dvt/vaginal bleeding of unknown origin
boolean
C1301624 (UMLS CUI [1,1])
C0039286 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
C2979982 (UMLS CUI [3,1])
C0332240 (UMLS CUI [3,2])
Dementia
Item
dementia
boolean
C0497327 (UMLS CUI [1])
Cancer Other Interferes with Tamoxifen Therapeutic procedure
Item
history of other malignancy that may interfere with at least 6 months of tamoxifen therapy
boolean
C1707251 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0039286 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
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