ID

31045

Description

Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00674258

Link

https://clinicaltrials.gov/show/NCT00674258

Keywords

Versions (1)
  1. 7/13/18 7/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00674258

English

Eligibility Non Small Cell Lung Cancer NCT00674258

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease characteristics
Description

Disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
advanced or recurrent non small cell lung cancer
Description

Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0278517
second line or later therapeutic status patient characteristics
Description

Second line treatment | Line of Therapy Ordinal number | Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C1710038
UMLS CUI [2,1]
C4524693
UMLS CUI [2,2]
C0439080
UMLS CUI [3]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
hla-a*2402
Description

HLA-A*2402

Data type

boolean

Alias
UMLS CUI [1]
C1098634
laboratory values as follows
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
2000/mm3<wbc<15000/mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
platelet count>100000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 3.0mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
asparate transaminase < 150iu/l
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
alanine transaminase < 150iu/l
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
creatinine < 3.0mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
able and willing to give valid written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception)
Description

Pregnancy | Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1705116
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
active or uncontrolled infection
Description

Communicable Disease | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
concurrent treatment with steroids or immunosuppressing agent
Description

Steroid therapy | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0021081
prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
Description

Prior Chemotherapy | Prior radiation therapy | Prior Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C1514461
uncontrolled brain and/or intraspinal metastasis
Description

Metastatic malignant neoplasm to brain Uncontrolled | Secondary malignant neoplasm of vertebral column Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0684550
UMLS CUI [2,2]
C0205318
decision of unsuitableness by principal investigator or physician-in-charge
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00674258

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Disease characteristic
Item
disease characteristics
boolean
C0599878 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer recurrent
Item
advanced or recurrent non small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
Second line treatment | Line of Therapy Ordinal number | Client Characteristics
Item
second line or later therapeutic status patient characteristics
boolean
C1710038 (UMLS CUI [1])
C4524693 (UMLS CUI [2,1])
C0439080 (UMLS CUI [2,2])
C0815172 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
HLA-A*2402
Item
hla-a*2402
boolean
C1098634 (UMLS CUI [1])
Laboratory Results
Item
laboratory values as follows
boolean
C1254595 (UMLS CUI [1])
White Blood Cell Count procedure
Item
2000/mm3<wbc<15000/mm3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count>100000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 3.0mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
asparate transaminase < 150iu/l
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine transaminase < 150iu/l
boolean
C0201836 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 3.0mg/dl
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
able and willing to give valid written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable
Item
pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Communicable Disease | Communicable Disease Uncontrolled
Item
active or uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Steroid therapy | Immunosuppressive Agents
Item
concurrent treatment with steroids or immunosuppressing agent
boolean
C0149783 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Prior Chemotherapy | Prior radiation therapy | Prior Immunotherapy
Item
prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
Metastatic malignant neoplasm to brain Uncontrolled | Secondary malignant neoplasm of vertebral column Uncontrolled
Item
uncontrolled brain and/or intraspinal metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0684550 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
decision of unsuitableness by principal investigator or physician-in-charge
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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