ID

26845

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00903162

Trefwoorden

Versies (1)
  1. 25-10-17 25-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00903162

Engels

Eligibility Breast Cancer NCT00903162

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Gender | Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Premenopausal state | Estradiol measurement Premenopausal state

Datatype

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
Beschrijving

Liver Function Tests | Creatinine measurement, serum

Datatype

boolean

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

ECOG performance status

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Pregnancy test negative

Datatype

boolean

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

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Diphosphonates Oral | Diphosphonates Intravenous

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Breast cancer recurrent Local | Secondary malignant neoplasm of female breast

Datatype

boolean

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

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
nursing women
Beschrijving

Breast Feeding

Datatype

boolean

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

Tamoxifen | Tamoxifen Discontinue Unwilling

Datatype

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
Beschrijving

Gender | BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00903162

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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