ID

26845

Descripción

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00903162

Link

https://clinicaltrials.gov/show/NCT00903162

Palabras clave

Versiones (1)
  1. 25/10/17 25/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

25 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 NCT00903162

Inglés

Eligibility Breast Cancer NCT00903162

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years of age or older
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
history of invasive er+ or pr+ breast cancer treated with at least 4.5 years of tamoxifen
Descripción

Invasive carcinoma of breast Estrogen receptor positive | Invasive carcinoma of breast Progesterone receptor positive | Tamoxifen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0279759
UMLS CUI [3]
C0039286
no current evidence of recurrent invasive disease or metastatic disease. patients may have a history of bilateral breast cancer
Descripción

Recurrent disease Invasive Absent | Neoplasm Metastasis Absent | Bilateral breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0281267
premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)
Descripción

Premenopausal state | Estradiol measurement Premenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0337434
UMLS CUI [2,2]
C0232969
liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment
Descripción

Liver Function Tests | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023901
UMLS CUI [2]
C0201976
ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
must agree to use non-hormonal contraception (condoms, diaphragm, iud, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped
Descripción

Contraceptive methods | Exception Hormonal contraception | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Female Sterilization | Sexual Abstinence | Hormone Therapy Absent | Letrozole Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
UMLS CUI [3]
C0221829
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0015787
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0279025
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0246421
UMLS CUI [9,2]
C1444662
negative pregnancy test within 14 days prior to enrollment
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
patient must be able to speak, read and write in english
Descripción

Able to speak English Language | Able to read English Language | Able to write English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an oral or iv bisphosphonate in the prior two years
Descripción

Diphosphonates Oral | Diphosphonates Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C1522726
history of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
Descripción

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
women with evidence of current local recurrence or metastatic breast cancer
Descripción

Breast cancer recurrent Local | Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C0346993
pregnant women
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
nursing women
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
women who are currently taking tamoxifen and are unwilling to stop this medication
Descripción

Tamoxifen | Tamoxifen Discontinue Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
women with a known deleterious brca 1 or brca 2 mutation
Descripción

Gender | BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0376571
UMLS CUI [2,2]
C2985436
UMLS CUI [3,1]
C0598034
UMLS CUI [3,2]
C2985436
Volver a la parte superior de la página

Similar models

Eligibility Breast Cancer NCT00903162

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast Estrogen receptor positive | Invasive carcinoma of breast Progesterone receptor positive | Tamoxifen
Item
history of invasive er+ or pr+ breast cancer treated with at least 4.5 years of tamoxifen
boolean
C0853879 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3])
Recurrent disease Invasive Absent | Neoplasm Metastasis Absent | Bilateral breast cancer
Item
no current evidence of recurrent invasive disease or metastatic disease. patients may have a history of bilateral breast cancer
boolean
C0277556 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281267 (UMLS CUI [3])
Premenopausal state | Estradiol measurement Premenopausal state
Item
premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)
boolean
C0232969 (UMLS CUI [1])
C0337434 (UMLS CUI [2,1])
C0232969 (UMLS CUI [2,2])
Liver Function Tests | Creatinine measurement, serum
Item
liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment
boolean
C0023901 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods | Exception Hormonal contraception | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Female Sterilization | Sexual Abstinence | Hormone Therapy Absent | Letrozole Discontinued
Item
must agree to use non-hormonal contraception (condoms, diaphragm, iud, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped
boolean
C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
C0221829 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0279025 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0246421 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
Pregnancy test negative
Item
negative pregnancy test within 14 days prior to enrollment
boolean
C0427780 (UMLS CUI [1])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
patient must be able to speak, read and write in english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Diphosphonates Oral | Diphosphonates Intravenous
Item
previous treatment with an oral or iv bisphosphonate in the prior two years
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0012544 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
history of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Breast cancer recurrent Local | Secondary malignant neoplasm of female breast
Item
women with evidence of current local recurrence or metastatic breast cancer
boolean
C0278493 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
nursing women
boolean
C0006147 (UMLS CUI [1])
Tamoxifen | Tamoxifen Discontinue Unwilling
Item
women who are currently taking tamoxifen and are unwilling to stop this medication
boolean
C0039286 (UMLS CUI [1])
C0039286 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Gender | BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation
Item
women with a known deleterious brca 1 or brca 2 mutation
boolean
C0079399 (UMLS CUI [1])
C0376571 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
C0598034 (UMLS CUI [3,1])
C2985436 (UMLS CUI [3,2])
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