ID

16450

Beschrijving

Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2; ODM derived from: https://clinicaltrials.gov/show/NCT00197522

Link

https://clinicaltrials.gov/show/NCT00197522

Trefwoorden

  1. 17-07-16 17-07-16 -
Geüploaded op

17 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00197522

Eligibility Breast Neoplasms NCT00197522

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with metastatic breast cancer who are her2/neu positive (3+ by immunohistochemistry or fish positive) and either
Beschrijving

her2/neu positive metastatic breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278488
UMLS CUI [1,2]
C1960398
1. currently receiving hormonal therapy or are candidates for such or
Beschrijving

hormonal therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
2. being considered for trastuzumab or
Beschrijving

trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0728747
3. their cancer has progressed on trastuzumab
Beschrijving

cancer has progressed on trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C1947901
UMLS CUI [1,2]
C0728747
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are excluded from the study if they meet any one of the following criteria:
Beschrijving

exclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
age less than 16 years.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
pregnant or lactating female.
Beschrijving

pregnant or lactating female

Datatype

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
previous malignancy other than non-melanoma skin cancer.
Beschrijving

previous malignancy other than non-melanoma skin cancer.

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C3281209
more than three prior courses of cytotoxic chemotherapy for metastatic disease.
Beschrijving

cytotoxic chemotherapy for metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C2939420
concurrent use of chemotherapy, immunotherapy, or gene therapy. concurrent hormonal therapy (tamoxifen, aromatase inhibitors or exemestane) is permitted.
Beschrijving

combined modality therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009429
treatment with trastuzumab within 16 weeks prior to first dose of vaccine therapy.
Beschrijving

trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0728747
documented central nervous system metastases.
Beschrijving

central nervous system metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
patients with any an acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy (ie. unstable angina, renal or liver failure, or severe chronic obstructive airways disease) are ineligible.
Beschrijving

acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0009488
any patients requiring concurrent immunosuppressive therapy (eg. corticosteroids)
Beschrijving

concurrent immunosuppressive therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205420
patients with a life expectancy of less than six months.
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of >2.
Beschrijving

ecog performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224

Similar models

Eligibility Breast Neoplasms NCT00197522

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
her2/neu positive metastatic breast cancer
Item
patients with metastatic breast cancer who are her2/neu positive (3+ by immunohistochemistry or fish positive) and either
boolean
C0278488 (UMLS CUI [1,1])
C1960398 (UMLS CUI [1,2])
hormonal therapy
Item
1. currently receiving hormonal therapy or are candidates for such or
boolean
C0279025 (UMLS CUI [1])
trastuzumab
Item
2. being considered for trastuzumab or
boolean
C0728747 (UMLS CUI [1])
cancer has progressed on trastuzumab
Item
3. their cancer has progressed on trastuzumab
boolean
C1947901 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
patients are excluded from the study if they meet any one of the following criteria:
boolean
C0680251 (UMLS CUI [1])
age
Item
age less than 16 years.
boolean
C0001779 (UMLS CUI [1])
pregnant or lactating female
Item
pregnant or lactating female.
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
previous malignancy other than non-melanoma skin cancer.
Item
previous malignancy other than non-melanoma skin cancer.
boolean
C0006826 (UMLS CUI [1])
C3281209 (UMLS CUI [2])
cytotoxic chemotherapy for metastatic disease
Item
more than three prior courses of cytotoxic chemotherapy for metastatic disease.
boolean
C0677881 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
combined modality therapy
Item
concurrent use of chemotherapy, immunotherapy, or gene therapy. concurrent hormonal therapy (tamoxifen, aromatase inhibitors or exemestane) is permitted.
boolean
C0009429 (UMLS CUI [1])
trastuzumab
Item
treatment with trastuzumab within 16 weeks prior to first dose of vaccine therapy.
boolean
C0728747 (UMLS CUI [1])
central nervous system metastases
Item
documented central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy
Item
patients with any an acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy (ie. unstable angina, renal or liver failure, or severe chronic obstructive airways disease) are ineligible.
boolean
C4061114 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
concurrent immunosuppressive therapy
Item
any patients requiring concurrent immunosuppressive therapy (eg. corticosteroids)
boolean
C0021079 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
life expectancy
Item
patients with a life expectancy of less than six months.
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
ecog performance status of >2.
boolean
C1520224 (UMLS CUI [1])

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