ID

36386

Beschrijving

Study of ESR1 Mutations in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02473120

Link

https://clinicaltrials.gov/show/NCT02473120

Trefwoorden

  1. 09-05-19 09-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 mei 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT02473120

Eligibility Metastatic Breast Cancer NCT02473120

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
woman aged superior to 18 years old
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
inform consent signed
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
metastatic breast cancer or loco-regionnaly advanced breast cancer
Beschrijving

Secondary malignant neoplasm of female breast | Advanced breast cancer Local-Regional

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C3495917
UMLS CUI [2,2]
C1947913
inoperable
Beschrijving

Inoperable

Datatype

boolean

Alias
UMLS CUI [1]
C0205187
with an indication to treat with aromatase inhibitor
Beschrijving

Indication Aromatase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0593802
treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease
Beschrijving

Aromatase Inhibitors Initiation | Stable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C1704686
UMLS CUI [2]
C0677946
without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution
Beschrijving

Prior Therapy Absent | Chemotherapy | Tamoxifen | Faslodex | Aromatase Inhibitors | Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0701491
UMLS CUI [5]
C0593802
UMLS CUI [6]
C0677850
treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)
Beschrijving

Aromatase Inhibitors alone | Aromatase Inhibitors Combination Targeted Therapy | trastuzumab | pertuzumab | bevacizumab | everolimus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C2985566
UMLS CUI [3]
C0728747
UMLS CUI [4]
C1328025
UMLS CUI [5]
C0796392
UMLS CUI [6]
C0541315
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no inform consent signed
Beschrijving

Informed Consent Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
patient under guardianship, curatorship
Beschrijving

Patient Guardianship

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
psychosocial disorder
Beschrijving

Psychosocial problem

Datatype

boolean

Alias
UMLS CUI [1]
C0740697
no affiliated or beneficiary of a social benefit system
Beschrijving

Social insurance Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C0332268

Similar models

Eligibility Metastatic Breast Cancer NCT02473120

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
woman aged superior to 18 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
inform consent signed
boolean
C0021430 (UMLS CUI [1])
Secondary malignant neoplasm of female breast | Advanced breast cancer Local-Regional
Item
metastatic breast cancer or loco-regionnaly advanced breast cancer
boolean
C0346993 (UMLS CUI [1])
C3495917 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
Inoperable
Item
inoperable
boolean
C0205187 (UMLS CUI [1])
Indication Aromatase Inhibitors
Item
with an indication to treat with aromatase inhibitor
boolean
C3146298 (UMLS CUI [1,1])
C0593802 (UMLS CUI [1,2])
Aromatase Inhibitors Initiation | Stable Disease
Item
treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease
boolean
C0593802 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0677946 (UMLS CUI [2])
Prior Therapy Absent | Chemotherapy | Tamoxifen | Faslodex | Aromatase Inhibitors | Adjuvant therapy
Item
without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0701491 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C0677850 (UMLS CUI [6])
Aromatase Inhibitors alone | Aromatase Inhibitors Combination Targeted Therapy | trastuzumab | pertuzumab | bevacizumab | everolimus
Item
treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)
boolean
C0593802 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C2985566 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
C1328025 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
C0541315 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
no inform consent signed
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Patient Guardianship
Item
patient under guardianship, curatorship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Psychosocial problem
Item
psychosocial disorder
boolean
C0740697 (UMLS CUI [1])
Social insurance Lacking
Item
no affiliated or beneficiary of a social benefit system
boolean
C0037435 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])

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