ID

38245

Beskrivning

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01239745

Länk

https://clinicaltrials.gov/show/NCT01239745

Nyckelord

Versioner (1)
  1. 2019-10-01 2019-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01239745

Engelsk

Eligibility Breast Neoplasms NCT01239745

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

Menopause Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0567312
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

Datatyp

boolean

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

Operative Surgical Procedure Breast Carcinoma | Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.
Beskrivning

Disease Free Duration | Status post Adjuvant therapy | Tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677850
UMLS CUI [3]
C0039286
patients whose tumour was estrogen receptor positive (er+).
Beskrivning

Neoplasm Estrogen receptor positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279754
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 | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
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
metastatic breast cancer or a contra lateral tumour.
Beskrivning

Secondary malignant neoplasm of female breast | Neoplasm Contralateral

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0441988
other concomitant adjuvant endocrine therapy.
Beskrivning

Hormone Therapy Adjuvant

Datatyp

boolean

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

Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
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
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Similar models

Eligibility Breast Neoplasms NCT01239745

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])
Menopause Duration
Item
1. natural menopause ≥1 year,
boolean
C0567312 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Ovariectomy
Item
2. surgical ovariectomy,
boolean
C0029936 (UMLS CUI [1])
Amenorrhea Chemotherapy Induced
Item
3. chemotherapy-induced amenorrhoea ≥ 2 years.
boolean
C0002453 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
Operative Surgical Procedure Breast Carcinoma | Neoplasm Metastasis Absent
Item
patients who have had surgical treatment for histologically 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])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease Free Duration | Status post Adjuvant therapy | Tamoxifen
Item
patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3])
Neoplasm Estrogen receptor positive
Item
patients whose tumour was estrogen receptor positive (er+).
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
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])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
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])
Secondary malignant neoplasm of female breast | Neoplasm Contralateral
Item
metastatic breast cancer or a contra lateral tumour.
boolean
C0346993 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Hormone Therapy Adjuvant
Item
other concomitant adjuvant endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Cancer treatment
Item
other concomitant antineoplastic treatment.
boolean
C0920425 (UMLS CUI [1])
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])
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