ID

37718

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01349842

Trefwoorden

  1. 19-08-19 19-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Gender | Age

Datatype

boolean

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

WHO performance status scale

Datatype

boolean

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

Secondary malignant neoplasm of female breast

Datatype

boolean

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

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

Datatype

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).
Beschrijving

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

Datatype

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.
Beschrijving

Carcinoma, Lobular | Ductal Breast Carcinoma

Datatype

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.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

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

Exclusion Criteria

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

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

Datatype

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.
Beschrijving

Neoplasm Metastasis TNM clinical staging | Exception Breast Carcinoma

Datatype

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.
Beschrijving

Histology | Exception Lobular Carcinoma | Exception Ductal Breast Carcinoma

Datatype

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.
Beschrijving

Pregnancy | Pregnancy Probable | Breast Feeding

Datatype

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.
Beschrijving

Persons Deprivation Freedom | Guardianship of person

Datatype

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.
Beschrijving

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

Datatype

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

Similar models

Eligibility Breast Cancer Ductal Infiltrating Metastatic NCT01349842

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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