ID

39082

Descripción

Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT01710605

Link

https://clinicaltrials.gov/show/NCT01710605

Palabras clave

Versiones (1)
  1. 28/11/19 28/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Ductal Infiltrating Metastatic Breast Cancer NCT01710605

Inglés

Eligibility Ductal Infiltrating Metastatic Breast Cancer NCT01710605

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with metastatic ductal adenocarcinoma breast cancer
Descripción

Gender | Ductal Breast Carcinoma metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1527349
UMLS CUI [2,2]
C1522484
18 years old or more
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
hormone receptors positive breast cancer (er+ and/or pr+) on the last pathological analysis available.
Descripción

Breast Carcinoma Hormone Receptor Positive | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C2938924
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0279759
acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
Descripción

Medical Status Compatible with Chemotherapy | Medical Status Compatible with Hormone Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C3899485
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0279025
ps <4
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
life expectancy > 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
evidence of measurable or evaluable disease (recist 1.1 criteria)in the 28 days before selection
Descripción

Measurable Disease | Evaluable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
information of the patient and signature of the informed consent form
Descripción

Patient Information | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1955348
UMLS CUI [2]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
Descripción

Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0027627
her2 positive breast cancer
Descripción

HER2-positive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960398
history of other stage ii or iii cancer in the 5 years. history of other metastatic cancer (whatever the time between the two cancers).
Descripción

Cancer Other TNM clinical staging | Neoplasm Metastasis Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205394
persons deprived of their freedom or under guardianship.
Descripción

Persons Deprivation Freedom | Persons Guardianship

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2,1]
C0027361
UMLS CUI [2,2]
C0870627
women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
Descripción

Gender | Follow-up Compliance Unable | Geographic Factors | Social situation | Mental condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0017444
UMLS CUI [4]
C0748872
UMLS CUI [5]
C3840291
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Similar models

Eligibility Ductal Infiltrating Metastatic Breast Cancer NCT01710605

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Ductal Breast Carcinoma metastatic
Item
women with metastatic ductal adenocarcinoma breast cancer
boolean
C0079399 (UMLS CUI [1])
C1527349 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Age
Item
18 years old or more
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Hormone Receptor Positive | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive
Item
hormone receptors positive breast cancer (er+ and/or pr+) on the last pathological analysis available.
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2938924 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
Medical Status Compatible with Chemotherapy | Medical Status Compatible with Hormone Therapy
Item
acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
boolean
C3899485 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C3899485 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
Performance status
Item
ps <4
boolean
C1518965 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
evidence of measurable or evaluable disease (recist 1.1 criteria)in the 28 days before selection
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Patient Information | Informed Consent
Item
information of the patient and signature of the informed consent form
boolean
C1955348 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis
Item
patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
HER2-positive carcinoma of breast
Item
her2 positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Cancer Other TNM clinical staging | Neoplasm Metastasis Other
Item
history of other stage ii or iii cancer in the 5 years. history of other metastatic cancer (whatever the time between the two cancers).
boolean
C1707251 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Persons Deprivation Freedom | Persons Guardianship
Item
persons deprived of their freedom or under guardianship.
boolean
C0027361 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0027361 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
Gender | Follow-up Compliance Unable | Geographic Factors | Social situation | Mental condition
Item
women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
boolean
C0079399 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0017444 (UMLS CUI [3])
C0748872 (UMLS CUI [4])
C3840291 (UMLS CUI [5])
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