ID

19656

Beschrijving

Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01249456

Link

https://clinicaltrials.gov/show/NCT01249456

Trefwoorden

Versies (1)
  1. 19-01-17 19-01-17 -
Geüploaded op

19 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01249456

Engels

Eligibility Breast Cancer NCT01249456

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
Beschrijving

Postmenopausal state | Breast Carcinoma Removed | Neoplasm Metastasis Absent | Adjuvant therapy Completed | Tamoxifen | Toremifene

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0849355
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0205197
UMLS CUI [5]
C0039286
UMLS CUI [6]
C0076836
age ≥50 years with cessation of menses and age ＜50 years postmenopausal status defined by one of the following:
Beschrijving

Age Amenorrhea | Age Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0002453
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0232970
fsh level ＞ 30-40 iu/l
Beschrijving

Follicle stimulating hormone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202022
cessation of menses over the past 1 year
Beschrijving

Amenorrhea Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
are/become amenorrheic due to either chemotherapy or lhrh, are/become amenorrheic due to surgical ovarian ablation
Beschrijving

Amenorrhea Due to Chemotherapy | Amenorrhea Due to Luteinizing Hormone-releasing Hormone Agonist | Amenorrhea Due to Ovarian ablation Surgical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1518041
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0677922
UMLS CUI [3,4]
C0543467
the tumor was to be er and/or pgr-positive or the receptor status could have been unknown
Beschrijving

Estrogen receptor positive tumor | Progesterone receptor positive tumor | estrogen receptor status unknown | progesterone receptor status unknown

Datatype

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2]
C1562928
UMLS CUI [3]
C0279758
UMLS CUI [4]
C0279768
no evidence of recurrence of the disease at entry
Beschrijving

Disease recurrence Evidence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C3887511
patient must be accessible for follow-up
Beschrijving

Patient Available Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
those patients known to have had receptor-negative primary tumors
Beschrijving

Hormone receptor negative neoplasm Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C2584453
UMLS CUI [1,2]
C0205225
any concurrent malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
patients who previously received hormone replacement therapy (hrt) during 5 years of adjuvant therapy with tamoxifen or toremifen
Beschrijving

Hormone replacement therapy | Adjuvant therapy | Tamoxifen | Toremifene

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0076836
patients who are currently receiving other aromatase inhibitors, or chemotherapy
Beschrijving

Aromatase Inhibitors | Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0392920
patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
Beschrijving

Cardiovascular Disease Serious | Liver disease Serious | Abnormal cardiovascular function Daily Significant | Liver function Abnormal Daily Significant | Laboratory Results Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0232090
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C0205161
UMLS CUI [4,3]
C0332173
UMLS CUI [4,4]
C0750502
UMLS CUI [5,1]
C1254595
UMLS CUI [5,2]
C0205161
life expectancy ＜ 12 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Breast Cancer NCT01249456

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent form
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Breast Carcinoma Removed | Neoplasm Metastasis Absent | Adjuvant therapy Completed | Tamoxifen | Toremifene
Item
postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
boolean
C0232970 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0849355 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0039286 (UMLS CUI [5])
C0076836 (UMLS CUI [6])
Age Amenorrhea | Age Postmenopausal state
Item
age ≥50 years with cessation of menses and age ＜50 years postmenopausal status defined by one of the following:
boolean
C0001779 (UMLS CUI [1,1])
C0002453 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
Follicle stimulating hormone measurement
Item
fsh level ＞ 30-40 iu/l
boolean
C0202022 (UMLS CUI [1])
Amenorrhea Duration
Item
cessation of menses over the past 1 year
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Amenorrhea Due to Chemotherapy | Amenorrhea Due to Luteinizing Hormone-releasing Hormone Agonist | Amenorrhea Due to Ovarian ablation Surgical
Item
are/become amenorrheic due to either chemotherapy or lhrh, are/become amenorrheic due to surgical ovarian ablation
boolean
C0002453 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1518041 (UMLS CUI [2,3])
C0002453 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0677922 (UMLS CUI [3,3])
C0543467 (UMLS CUI [3,4])
Estrogen receptor positive tumor | Progesterone receptor positive tumor | estrogen receptor status unknown | progesterone receptor status unknown
Item
the tumor was to be er and/or pgr-positive or the receptor status could have been unknown
boolean
C1562312 (UMLS CUI [1])
C1562928 (UMLS CUI [2])
C0279758 (UMLS CUI [3])
C0279768 (UMLS CUI [4])
Disease recurrence Evidence
Item
no evidence of recurrence of the disease at entry
boolean
C0679254 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Patient Available Follow-up
Item
patient must be accessible for follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hormone receptor negative neoplasm Primary
Item
those patients known to have had receptor-negative primary tumors
boolean
C2584453 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Malignant Neoplasms
Item
any concurrent malignancy
boolean
C0006826 (UMLS CUI [1])
Hormone replacement therapy | Adjuvant therapy | Tamoxifen | Toremifene
Item
patients who previously received hormone replacement therapy (hrt) during 5 years of adjuvant therapy with tamoxifen or toremifen
boolean
C0282402 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0076836 (UMLS CUI [4])
Aromatase Inhibitors | Chemotherapy
Item
patients who are currently receiving other aromatase inhibitors, or chemotherapy
boolean
C0593802 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Cardiovascular Disease Serious | Liver disease Serious | Abnormal cardiovascular function Daily Significant | Liver function Abnormal Daily Significant | Laboratory Results Abnormal
Item
patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0232090 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C0232741 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
C0750502 (UMLS CUI [4,4])
C1254595 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
Life Expectancy
Item
life expectancy ＜ 12 months
boolean
C0023671 (UMLS CUI [1])
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