ID

31225

Description

A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT00655161

Link

https://clinicaltrials.gov/show/NCT00655161

Keywords

  1. 7/30/18 7/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility NSCLC NCT00655161

Eligibility NSCLC NCT00655161

  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT00655161
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically proven stage i-iii nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
confirmed product related ras mutation
Description

RAS Mutation Product Related

Data type

boolean

Alias
UMLS CUI [1,1]
C4331205
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0439849
ecog performance status of less than or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
greater than or equal to 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of a previous cancer
Description

Malignant Neoplasms Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
history of splenectomy
Description

Splenectomy

Data type

boolean

Alias
UMLS CUI [1]
C0037995
history of crohns disease or ulcerative colitis
Description

Crohn Disease | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0009324
history of major organ transplantation
Description

Transplantation Organ Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
concurrent or chronic steroid therapy
Description

Steroid therapy | Steroid therapy chronic

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205191
history of allergy to yeast
Description

Allergy to yeast

Data type

boolean

Alias
UMLS CUI [1]
C3875439
presence of an unstable or poorly controlled medical condition
Description

Medical condition Unstable | Medical condition Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C3853134
pregnant or nursing mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive skin test to yeast
Description

Skin test for candida Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0344445
UMLS CUI [1,2]
C1514241

Similar models

Eligibility NSCLC NCT00655161

  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT00655161
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
pathologically proven stage i-iii nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
RAS Mutation Product Related
Item
confirmed product related ras mutation
boolean
C4331205 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms Previous
Item
history of a previous cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Splenectomy
Item
history of splenectomy
boolean
C0037995 (UMLS CUI [1])
Crohn Disease | Ulcerative Colitis
Item
history of crohns disease or ulcerative colitis
boolean
C0010346 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
Transplantation Organ Major
Item
history of major organ transplantation
boolean
C0040732 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Steroid therapy | Steroid therapy chronic
Item
concurrent or chronic steroid therapy
boolean
C0149783 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Allergy to yeast
Item
history of allergy to yeast
boolean
C3875439 (UMLS CUI [1])
Medical condition Unstable | Medical condition Poorly controlled
Item
presence of an unstable or poorly controlled medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Skin test for candida Positive
Item
positive skin test to yeast
boolean
C0344445 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])

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