ID

26057

Descripción

A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00488722

Link

https://clinicaltrials.gov/show/NCT00488722

Palabras clave

Versiones (1)
  1. 5/10/17 5/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de octubre de 2017

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 Breast Cancer NCT00488722

Inglés

Eligibility Breast Cancer NCT00488722

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. pathological confirmation of breast cancer
Descripción

Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
3. tumor stage(tnm):t2-4bn0-3m0
Descripción

TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3258246
4. er(+) and/or pr(+).
Descripción

Estrogen receptor positive | Progesterone receptor positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
5. premenopausal woman.
Descripción

Premenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232969
6. age≥40 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
7. measurable disease as per recist criteria
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
8. karnofsky≥70
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
9. labratory criteria:
Descripción

Laboratory criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
plt≥100*109/l
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
wbc≥4000/mm3
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
hgb≥10g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
alt and ast<2*uln
Descripción

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of metastatic disease.
Descripción

Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
2. inflammatory breast cancer.
Descripción

Inflammatory Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278601
3. bilateral breast cancer.
Descripción

bilateral breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281267
4. previous chemotherapy or hormonal therapyfor current breast neoplasm.
Descripción

Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678222
5. other malignant tumor (concurrent or previous).
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
6. pregnant woman.
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
Descripción

Hypersensitivity Pharmaceutical Preparations CEF regimen | Hypersensitivity Zoladex Ingredient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0248241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0149473
UMLS CUI [2,3]
C1550600
8. any severe systemic disease contraindicating chemotherapy.
Descripción

Systemic disease Severe | Medical contraindication Chemotherapy Regimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920
Volver a la parte superior de la página

Similar models

Eligibility Breast Cancer NCT00488722

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. pathological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
TNM clinical staging
Item
3. tumor stage(tnm):t2-4bn0-3m0
boolean
C3258246 (UMLS CUI [1])
Estrogen receptor positive | Progesterone receptor positive
Item
4. er(+) and/or pr(+).
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Premenopausal state
Item
5. premenopausal woman.
boolean
C0232969 (UMLS CUI [1])
Age
Item
6. age≥40 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
8. karnofsky≥70
boolean
C0206065 (UMLS CUI [1])
Laboratory criteria
Item
9. labratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Platelet Count measurement
Item
plt≥100*109/l
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc≥4000/mm3
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb≥10g/dl
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast<2*uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
1. presence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
2. inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
bilateral breast cancer
Item
3. bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma
Item
4. previous chemotherapy or hormonal therapyfor current breast neoplasm.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms
Item
5. other malignant tumor (concurrent or previous).
boolean
C0006826 (UMLS CUI [1])
Pregnancy
Item
6. pregnant woman.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparations CEF regimen | Hypersensitivity Zoladex Ingredient
Item
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0248241 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0149473 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Systemic disease Severe | Medical contraindication Chemotherapy Regimen
Item
8. any severe systemic disease contraindicating chemotherapy.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
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