ID

40466

Beskrivning

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01121549

Länk

https://clinicaltrials.gov/show/NCT01121549

Nyckelord

Versioner (1)
  1. 2020-04-23 2020-04-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Invasive Early Breast Cancer NCT01121549

Engelsk

Eligibility Invasive Early Breast Cancer NCT01121549

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal females, defined as one from the next :
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
1. natural menopause >/=1 year,
Beskrivning

Natural menopause Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0856856
UMLS CUI [1,2]
C0449238
2. surgical ovariectomy,
Beskrivning

Ovariectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0029936
3. chemotherapy-induced amenorrhoea >/=2 years.
Beskrivning

Amenorrhea Chemotherapy-induced | Amenorrhea Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205263
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
Beskrivning

Operative Surgical Procedure Breast Carcinoma nonmetastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1518409
patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
Beskrivning

Patients Disease Free of | Status post Tamoxifen Adjuvant therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0039286
UMLS CUI [2,3]
C0677850
patients whose tumour was estrogen receptor positive (er+).
Beskrivning

Estrogen receptor positive tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C1562312
evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients for whom aromasin® treatment is contraindicated (see smpc).
Beskrivning

Medical contraindication Aromasin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0876723
presence of metastasis or a contra lateral tumour.
Beskrivning

Neoplasm Metastasis | Neoplasm Contralateral

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0441988
other adjuvant endocrine therapy.
Beskrivning

Hormone Therapy Adjuvant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
another concomitant antineoplastic treatment
Beskrivning

Cancer treatment Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
the patients are not supposed to participate to any other trial during all the study period.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Invasive Early Breast Cancer NCT01121549

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal females, defined as one from the next :
boolean
C0232970 (UMLS CUI [1])
Natural menopause Duration
Item
1. natural menopause >/=1 year,
boolean
C0856856 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Ovariectomy
Item
2. surgical ovariectomy,
boolean
C0029936 (UMLS CUI [1])
Amenorrhea Chemotherapy-induced | Amenorrhea Duration
Item
3. chemotherapy-induced amenorrhoea >/=2 years.
boolean
C0002453 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Operative Surgical Procedure Breast Carcinoma nonmetastatic
Item
patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1518409 (UMLS CUI [1,3])
Patients Disease Free of | Status post Tamoxifen Adjuvant therapy
Item
patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
boolean
C0030705 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0039286 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,3])
Estrogen receptor positive tumor
Item
patients whose tumour was estrogen receptor positive (er+).
boolean
C1562312 (UMLS CUI [1])
Informed Consent
Item
evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Aromasin
Item
patients for whom aromasin® treatment is contraindicated (see smpc).
boolean
C1301624 (UMLS CUI [1,1])
C0876723 (UMLS CUI [1,2])
Neoplasm Metastasis | Neoplasm Contralateral
Item
presence of metastasis or a contra lateral tumour.
boolean
C0027627 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Hormone Therapy Adjuvant
Item
other adjuvant endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Cancer treatment Other
Item
another concomitant antineoplastic treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
the patients are not supposed to participate to any other trial during all the study period.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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