ID

19656

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01249456

Nyckelord

Versioner (1)
  1. 2017-01-19 2017-01-19 -
Uppladdad den

19 januari 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT01249456

Engelsk

Eligibility Breast Cancer NCT01249456

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent form
Beskrivning

Informed Consent

Datatyp

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
Beskrivning

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

Datatyp

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:
Beskrivning

Age Amenorrhea | Age Postmenopausal state

Datatyp

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
Beskrivning

Follicle stimulating hormone measurement

Datatyp

boolean

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

Amenorrhea Duration

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Disease recurrence Evidence

Datatyp

boolean

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

Patient Available Follow-up

Datatyp

boolean

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

Exclusion Criteria

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

Hormone receptor negative neoplasm Primary

Datatyp

boolean

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

Malignant Neoplasms

Datatyp

boolean

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

Hormone replacement therapy | Adjuvant therapy | Tamoxifen | Toremifene

Datatyp

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
Beskrivning

Aromatase Inhibitors | Chemotherapy

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01249456

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial