ID

13771

Descrição

Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01398124

Link

https://clinicaltrials.gov/show/NCT01398124

Palavras-chave

Versões (1)
  1. 06/03/2016 06/03/2016 -
Transferido a

6 de março de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01398124

Inglês

Eligibility Non-small Cell Lung Cancer NCT01398124

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically or cytologically confirmed non-small cell lung cancer
Descrição

non-small cell lung cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
all patients must have one of the following stages: stage ia(t1no), and ib t2no), ii & iiia (n2 negative)
Descrição

tumor stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1300072
no prior chemotherapy or radiation therapy for non-small cell lung cancer
Descrição

chemotherapy non-small cell lung cancer; radiation therapy non-small cell lung cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0007131
age >18 years
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status <2
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients must have acceptable organ and marrow
Descrição

organ; bone marrow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178784
UMLS CUI [2]
C0005953
patient must be deemed surgically and medically resectable
Descrição

resectable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514888
men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter.
Descrição

Contraception status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0420837
ability to understand and the willingness to sign a written informed consent document.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be receiving any other investigational agents.
Descrição

study drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
patients should not have received chemotherapy or radiotherapy within 3 months prior to entry to study.
Descrição

chemotherapy; radiotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0034619
patients with tumors involving the superior sulcus are not eligible.
Descrição

Pancoast Tumor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549471
patients must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
Descrição

Compliance behavior Limited Comorbidity; post-obstructive pneumonia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0747690
prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
Descrição

Lung tumor excision

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0565000
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Compliance behavior Limited Comorbidity; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0004936
pregnant women are excluded from this study. women of childbearing potential must have a negative pregnancy test.
Descrição

pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
known hiv-positive patients are excluded from the study.
Descrição

hiv-positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
patients with a history of known autoimmune disease are excluded from this study.
Descrição

autoimmune disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01398124

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
non-small cell lung cancer
Item
patients must have histologically or cytologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
tumor stage
Item
all patients must have one of the following stages: stage ia(t1no), and ib t2no), ii & iiia (n2 negative)
boolean
C1300072 (UMLS CUI [1])
chemotherapy non-small cell lung cancer; radiation therapy non-small cell lung cancer
Item
no prior chemotherapy or radiation therapy for non-small cell lung cancer
boolean
C3665472 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog performance status <2
boolean
C1520224 (UMLS CUI [1])
organ; bone marrow
Item
patients must have acceptable organ and marrow
boolean
C0178784 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
resectable
Item
patient must be deemed surgically and medically resectable
boolean
C1514888 (UMLS CUI [1])
Contraception status
Item
men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter.
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
study drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
chemotherapy; radiotherapy
Item
patients should not have received chemotherapy or radiotherapy within 3 months prior to entry to study.
boolean
C0392920 (UMLS CUI [1])
C0034619 (UMLS CUI [2])
Pancoast Tumor
Item
patients with tumors involving the superior sulcus are not eligible.
boolean
C0549471 (UMLS CUI [1])
Compliance behavior Limited Comorbidity; post-obstructive pneumonia
Item
patients must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0747690 (UMLS CUI [2])
Lung tumor excision
Item
prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
boolean
C0565000 (UMLS CUI [1])
Compliance behavior Limited Comorbidity; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; Mental disorders
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
pregnancy
Item
pregnant women are excluded from this study. women of childbearing potential must have a negative pregnancy test.
boolean
C0032961 (UMLS CUI [1])
hiv-positive
Item
known hiv-positive patients are excluded from the study.
boolean
C0019699 (UMLS CUI [1])
autoimmune disease
Item
patients with a history of known autoimmune disease are excluded from this study.
boolean
C0004364 (UMLS CUI [1])
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