ID

16450

Beschreibung

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

Stichworte

  1. 17.07.16 17.07.16 -
Hochgeladen am

17. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00197522

Eligibility Breast Neoplasms NCT00197522

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

her2/neu positive metastatic breast cancer

Datentyp

boolean

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

hormonal therapy

Datentyp

boolean

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

trastuzumab

Datentyp

boolean

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

cancer has progressed on trastuzumab

Datentyp

boolean

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

Exclusion Criteria

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

exclusion criteria

Datentyp

boolean

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

age

Datentyp

boolean

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

pregnant or lactating female

Datentyp

boolean

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

previous malignancy other than non-melanoma skin cancer.

Datentyp

boolean

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

cytotoxic chemotherapy for metastatic disease

Datentyp

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.
Beschreibung

combined modality therapy

Datentyp

boolean

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

trastuzumab

Datentyp

boolean

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

central nervous system metastases

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

concurrent immunosuppressive therapy

Datentyp

boolean

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

life expectancy

Datentyp

boolean

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

ecog performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224

Ähnliche Modelle

Eligibility Breast Neoplasms NCT00197522

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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