ID

37718

Description

Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01349842

Link

https://clinicaltrials.gov/show/NCT01349842

Keywords

Versions (1)
  1. 8/19/19 8/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

English

Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women over the age of 18 years.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
who performance status: 0 to 4.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
metastatic breast cancer.
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy.
Description

Disease Progression | Status post Line Quantity Chemotherapy | Initiation Third line Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C4524693
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C3665472
UMLS CUI [3,1]
C1704686
UMLS CUI [3,2]
C2986605
UMLS CUI [3,3]
C3665472
disease evaluable by ctc (ctc-positive before starting chemotherapy).
Description

Evaluable Disease Circulating Tumor Cell Analysis | Circulating Neoplastic Cells Positive Before Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1516986
UMLS CUI [1,2]
C3899622
UMLS CUI [2,1]
C0027625
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0392920
histology: lobular or ductal adenocarcinoma.
Description

Carcinoma, Lobular | Ductal Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0206692
UMLS CUI [2]
C1527349
information of the patient and signature of the informed consent form by the patient or her legal representative.
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
disease not evaluable by ctc (ctc-negative before starting chemotherapy).
Description

Disease Evaluation Unsuccessful Circulating Tumor Cell Analysis | Circulating Neoplastic Cells Negative Before Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1272705
UMLS CUI [1,4]
C3899622
UMLS CUI [2,1]
C0027625
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0392920
history of other potentially metastatic cancer (stage iii or iv cancer) different from breast cancer.
Description

Neoplasm Metastasis TNM clinical staging | Exception Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
histology other than lobular or ductal adenocarcinoma.
Description

Histology | Exception Lobular Carcinoma | Exception Ductal Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0344441
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0206692
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1527349
pregnant woman, women likely to become pregnant or nursing mothers.
Description

Pregnancy | Pregnancy Probable | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0033204
UMLS CUI [3]
C0006147
persons deprived of their freedom or under guardianship.
Description

Persons Deprivation Freedom | Guardianship of person

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2]
C0680611
women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
Description

Gender | Follow-up Unsuccessful Due to Geographic Factors | Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to Mental condition

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0017444
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1272705
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0337460
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C1272705
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C3840291
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Similar models

Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women over the age of 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
WHO performance status scale
Item
who performance status: 0 to 4.
boolean
C1298650 (UMLS CUI [1])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer.
boolean
C0346993 (UMLS CUI [1])
Disease Progression | Status post Line Quantity Chemotherapy | Initiation Third line Chemotherapy
Item
progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C4524693 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3665472 (UMLS CUI [2,4])
C1704686 (UMLS CUI [3,1])
C2986605 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
Evaluable Disease Circulating Tumor Cell Analysis | Circulating Neoplastic Cells Positive Before Chemotherapy
Item
disease evaluable by ctc (ctc-positive before starting chemotherapy).
boolean
C1516986 (UMLS CUI [1,1])
C3899622 (UMLS CUI [1,2])
C0027625 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
Carcinoma, Lobular | Ductal Breast Carcinoma
Item
histology: lobular or ductal adenocarcinoma.
boolean
C0206692 (UMLS CUI [1])
C1527349 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative
Item
information of the patient and signature of the informed consent form by the patient or her legal representative.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Disease Evaluation Unsuccessful Circulating Tumor Cell Analysis | Circulating Neoplastic Cells Negative Before Chemotherapy
Item
disease not evaluable by ctc (ctc-negative before starting chemotherapy).
boolean
C0012634 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C3899622 (UMLS CUI [1,4])
C0027625 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
Neoplasm Metastasis TNM clinical staging | Exception Breast Carcinoma
Item
history of other potentially metastatic cancer (stage iii or iv cancer) different from breast cancer.
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Histology | Exception Lobular Carcinoma | Exception Ductal Breast Carcinoma
Item
histology other than lobular or ductal adenocarcinoma.
boolean
C0344441 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0206692 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1527349 (UMLS CUI [3,2])
Pregnancy | Pregnancy Probable | Breast Feeding
Item
pregnant woman, women likely to become pregnant or nursing mothers.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Persons Deprivation Freedom | Guardianship of person
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])
C0680611 (UMLS CUI [2])
Gender | Follow-up Unsuccessful Due to Geographic Factors | Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to 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])
C1272705 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017444 (UMLS CUI [2,4])
C3274571 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0337460 (UMLS CUI [3,4])
C3274571 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C3840291 (UMLS CUI [4,4])
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