ID

40466

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01121549

Palabras clave

Versiones (1)
  1. 23/4/20 23/4/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de abril de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Invasive Early Breast Cancer NCT01121549

Inglés

Eligibility Invasive Early Breast Cancer NCT01121549

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Postmenopausal state

Tipo de datos

boolean

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

Natural menopause Duration

Tipo de datos

boolean

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

Ovariectomy

Tipo de datos

boolean

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

Amenorrhea Chemotherapy-induced | Amenorrhea Duration

Tipo de datos

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.
Descripción

Operative Surgical Procedure Breast Carcinoma nonmetastatic

Tipo de datos

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.
Descripción

Patients Disease Free of | Status post Tamoxifen Adjuvant therapy

Tipo de datos

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+).
Descripción

Estrogen receptor positive tumor

Tipo de datos

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.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Medical contraindication Aromasin

Tipo de datos

boolean

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

Neoplasm Metastasis | Neoplasm Contralateral

Tipo de datos

boolean

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

Hormone Therapy Adjuvant

Tipo de datos

boolean

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

Cancer treatment Other

Tipo de datos

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.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

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.
Descripción

Study Subject Participation Status | Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
Volver a la parte superior de la página

Similar models

Eligibility Invasive Early Breast Cancer NCT01121549

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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