ID

14455

Descripción

Phase IIb Randomized Controlled Study of BLP25 Liposome Vaccine for Immunotherapy of Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00157209

Link

https://clinicaltrials.gov/show/NCT00157209

Palabras clave

  1. 15/4/16 15/4/16 -
Subido en

15 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Lung Neoplasms NCT00157209

Eligibility Lung Neoplasms NCT00157209

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iiib or stage iv nsclc
Descripción

NSCLC staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278984
UMLS CUI [2]
C0278987
stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. patients must have completed the first-line treatment at least 3 weeks prior to study entry
Descripción

Treatment details

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2]
C1708063
UMLS CUI [3]
C0392920
UMLS CUI [4]
C3839414
UMLS CUI [5]
C0580352
ecog performance status of ≤2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
ability to understand and willingness to sign a written informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
received immunotherapy within 4 weeks prior to study entry
Descripción

Immunotherapy: date

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C2584899
received immunosuppressive drugs within 3 weeks prior to study entry
Descripción

Immunosupression: date

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C2584899
patients with known brain metastases
Descripción

Brain metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
Descripción

Further malignancies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0242793
autoimmune disease or immunodeficiency
Descripción

Autoimmune disease or immunodeficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
clinically significant hepatic, renal or cardiac dysfunction
Descripción

Liver, renal and cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
patients with clinically significant active infection
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
Descripción

Gynaecological status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0700589

Similar models

Eligibility Lung Neoplasms NCT00157209

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
NSCLC staging
Item
stage iiib or stage iv nsclc
boolean
C0278984 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
Treatment details
Item
stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. patients must have completed the first-line treatment at least 3 weeks prior to study entry
boolean
C1704632 (UMLS CUI [1])
C1708063 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C3839414 (UMLS CUI [4])
C0580352 (UMLS CUI [5])
ECOG performance status
Item
ecog performance status of ≤2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
ability to understand and willingness to sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunotherapy: date
Item
received immunotherapy within 4 weeks prior to study entry
boolean
C0021083 (UMLS CUI [1])
C2584899 (UMLS CUI [2])
Immunosupression: date
Item
received immunosuppressive drugs within 3 weeks prior to study entry
boolean
C0021079 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
Brain metastases
Item
patients with known brain metastases
boolean
C0220650 (UMLS CUI [1])
Further malignancies
Item
past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])
Autoimmune disease or immunodeficiency
Item
autoimmune disease or immunodeficiency
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Liver, renal and cardiac function
Item
clinically significant hepatic, renal or cardiac dysfunction
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
Infection
Item
patients with clinically significant active infection
boolean
C0009450 (UMLS CUI [1])
Gynaecological status
Item
pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4])

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