ID

38243

Description

Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01232062

Link

https://clinicaltrials.gov/show/NCT01232062

Keywords

  1. 10/1/19 10/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 1, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT01232062

Eligibility Breast Neoplasms NCT01232062

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
failure to anthracycline and/or taxol chemotherapy;
Description

Chemotherapy failed | Anthracyclines | Taxol

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0678133
metastatic tumor is histologically confirmed by immunohistochemical staining to be er-negative and pr-negative. fish testing for her-2-negative;
Description

Neoplasm Metastasis Estrogen receptor negative Immunohistochemistry | Neoplasm Metastasis Progesterone receptor negative Immunohistochemistry | HER2 Negative FISH

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0279756
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0279766
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C2348908
UMLS CUI [3,2]
C0162789
metastatic tumor can not be removed through surgery procedure;
Description

Neoplasm Metastasis Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205187
metastatic tumor measured by pet-ct scan is at least 1cm;
Description

Neoplasm Metastasis Size PET/CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1699633
an eastern cooperative oncology group (ecog) performance status of 0-2;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
normal cardiac, hepatic, renal and bone marrow functions;
Description

Cardiac function | Liver function | Renal function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
life expectancy ≥3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
do not finish twice pet-ct scan;
Description

PET/CT scan Twice

Data type

boolean

Alias
UMLS CUI [1,1]
C1699633
UMLS CUI [1,2]
C1948050
central nervous system metastases;
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
serious or uncontrolled concurrent medical illness;
Description

Comorbidity Serious | Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
history of other malignancies;
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
having been enrolled in some other clinal trials within a month;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Breast Neoplasms NCT01232062

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chemotherapy failed | Anthracyclines | Taxol
Item
failure to anthracycline and/or taxol chemotherapy;
boolean
C0392920 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0678133 (UMLS CUI [3])
Neoplasm Metastasis Estrogen receptor negative Immunohistochemistry | Neoplasm Metastasis Progesterone receptor negative Immunohistochemistry | HER2 Negative FISH
Item
metastatic tumor is histologically confirmed by immunohistochemical staining to be er-negative and pr-negative. fish testing for her-2-negative;
boolean
C0027627 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0279766 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C2348908 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
Neoplasm Metastasis Inoperable
Item
metastatic tumor can not be removed through surgery procedure;
boolean
C0027627 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Neoplasm Metastasis Size PET/CT scan
Item
metastatic tumor measured by pet-ct scan is at least 1cm;
boolean
C0027627 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
ECOG performance status
Item
an eastern cooperative oncology group (ecog) performance status of 0-2;
boolean
C1520224 (UMLS CUI [1])
Cardiac function | Liver function | Renal function | Bone Marrow function
Item
normal cardiac, hepatic, renal and bone marrow functions;
boolean
C0232164 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
Life Expectancy
Item
life expectancy ≥3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
PET/CT scan Twice
Item
do not finish twice pet-ct scan;
boolean
C1699633 (UMLS CUI [1,1])
C1948050 (UMLS CUI [1,2])
CNS metastases
Item
central nervous system metastases;
boolean
C0686377 (UMLS CUI [1])
Comorbidity Serious | Comorbidity Uncontrolled
Item
serious or uncontrolled concurrent medical illness;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Cancer Other
Item
history of other malignancies;
boolean
C1707251 (UMLS CUI [1])
Study Subject Participation Status
Item
having been enrolled in some other clinal trials within a month;
boolean
C2348568 (UMLS CUI [1])

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