ID

39082

Description

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

Keywords

Versions (1)
  1. 11/28/19 11/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Ductal Infiltrating Metastatic Breast Cancer NCT01710605

English

Eligibility Ductal Infiltrating Metastatic Breast Cancer NCT01710605

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Ductal Breast Carcinoma metastatic

Data type

boolean

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

Age

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

Performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Measurable Disease | Evaluable Disease

Data type

boolean

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

Patient Information | Informed Consent

Data type

boolean

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

Exclusion Criteria

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

Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis

Data type

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
Description

HER2-positive carcinoma of breast

Data type

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).
Description

Cancer Other TNM clinical staging | Neoplasm Metastasis Other

Data type

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.
Description

Persons Deprivation Freedom | Persons Guardianship

Data type

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.
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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