ID

17921

Description

A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00089726

Link

https://clinicaltrials.gov/show/NCT00089726

Keywords

Versions (1)
  1. 10/9/16 10/9/16 -
Uploaded on

October 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00089726

English

Eligibility Lung Cancer NCT00089726

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
suspicious diagnosis of or histologically- confirmed stage iiib or iv non small-cell lung cancer
Description

Non-Small Cell Lung Carcinoma | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
accessible and adequate tumor source for vaccine production.
Description

Carcinoma Source accessibility Adequate Vaccine Production

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0449416
UMLS CUI [1,3]
C0814423
UMLS CUI [1,4]
C0205411
UMLS CUI [1,5]
C1519894
tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
Description

Carcinoma Source Vaccine Production Accessibility Minor Surgical Procedure | Minor Surgical Procedure Local anesthesia | Minor Surgical Procedure Conduction Anesthesia | lymph node | Soft tissue mass | Pleural Effusion, Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0449416
UMLS CUI [1,3]
C1519894
UMLS CUI [1,4]
C0814423
UMLS CUI [1,5]
C0038904
UMLS CUI [2,1]
C0038904
UMLS CUI [2,2]
C0002921
UMLS CUI [3,1]
C0038904
UMLS CUI [3,2]
C0002911
UMLS CUI [4]
C0024204
UMLS CUI [5]
C0457193
UMLS CUI [6]
C0080032
measurable disease to evaluate following tumor procurement
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
limited metastatic tumor burden
Description

Tumor Burden Metastatic Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C0036525
UMLS CUI [1,3]
C0439801
life expectancy at least 4 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0 - 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active and/or untreated brain metastases
Description

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain untreated

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332155
active or impending spinal cord compression
Description

Compression of spinal cord | Compression of spinal cord Impending

Data type

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2,1]
C0037926
UMLS CUI [2,2]
C0332190
active auto-immune disease or treatment with immunosuppressants
Description

Autoimmune Disease | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021081
decompensated congestive heart failure or recent significant cardiac event
Description

CONGESTIVE HEART FAILURE DECOMPENSATED | cardiac event Significant Recent

Data type

boolean

Alias
UMLS CUI [1]
C0742746
UMLS CUI [2,1]
C0741923
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0332185
coexisting malignancies
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
Description

medical condition Significant Increase Complication of surgical procedure At risk | medical condition Uncontrolled Increase Complication of surgical procedure At risk | LABORATORY ABNORMALITIES Increase Complication of surgical procedure At risk | medical condition Significant Increase Vaccine Therapy At risk | medical condition Uncontrolled Increase Vaccine Therapy At risk | LABORATORY ABNORMALITIES Increase Vaccine Therapy At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0442805
UMLS CUI [1,4]
C0274311
UMLS CUI [1,5]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0442805
UMLS CUI [2,4]
C0274311
UMLS CUI [2,5]
C1444641
UMLS CUI [3,1]
C1853129
UMLS CUI [3,2]
C0442805
UMLS CUI [3,3]
C0274311
UMLS CUI [3,4]
C1444641
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0750502
UMLS CUI [4,3]
C0442805
UMLS CUI [4,4]
C0042209
UMLS CUI [4,5]
C1444641
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0442805
UMLS CUI [5,4]
C0042209
UMLS CUI [5,5]
C1444641
UMLS CUI [6,1]
C1853129
UMLS CUI [6,2]
C0442805
UMLS CUI [6,3]
C0042209
UMLS CUI [6,4]
C1444641
previous treatment with gene therapy (including any adenoviral-based therapy)
Description

gene therapy | Therapeutic procedure Based Adenoviral

Data type

boolean

Alias
UMLS CUI [1]
C0017296
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1705938
UMLS CUI [2,3]
C0001483
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Similar models

Eligibility Lung Cancer NCT00089726

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | TNM clinical staging
Item
suspicious diagnosis of or histologically- confirmed stage iiib or iv non small-cell lung cancer
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Carcinoma Source accessibility Adequate Vaccine Production
Item
accessible and adequate tumor source for vaccine production.
boolean
C0007097 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
C0814423 (UMLS CUI [1,3])
C0205411 (UMLS CUI [1,4])
C1519894 (UMLS CUI [1,5])
Carcinoma Source Vaccine Production Accessibility Minor Surgical Procedure | Minor Surgical Procedure Local anesthesia | Minor Surgical Procedure Conduction Anesthesia | lymph node | Soft tissue mass | Pleural Effusion, Malignant
Item
tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
boolean
C0007097 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
C1519894 (UMLS CUI [1,3])
C0814423 (UMLS CUI [1,4])
C0038904 (UMLS CUI [1,5])
C0038904 (UMLS CUI [2,1])
C0002921 (UMLS CUI [2,2])
C0038904 (UMLS CUI [3,1])
C0002911 (UMLS CUI [3,2])
C0024204 (UMLS CUI [4])
C0457193 (UMLS CUI [5])
C0080032 (UMLS CUI [6])
measurable disease
Item
measurable disease to evaluate following tumor procurement
boolean
C1513041 (UMLS CUI [1])
Tumor Burden Metastatic Limited
Item
limited metastatic tumor burden
boolean
C1449699 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy at least 4 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain untreated
Item
active and/or untreated brain metastases
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Compression of spinal cord | Compression of spinal cord Impending
Item
active or impending spinal cord compression
boolean
C0037926 (UMLS CUI [1])
C0037926 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
Autoimmune Disease | Immunosuppressive Agents
Item
active auto-immune disease or treatment with immunosuppressants
boolean
C0004364 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
CONGESTIVE HEART FAILURE DECOMPENSATED | cardiac event Significant Recent
Item
decompensated congestive heart failure or recent significant cardiac event
boolean
C0742746 (UMLS CUI [1])
C0741923 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Malignant Neoplasms
Item
coexisting malignancies
boolean
C0006826 (UMLS CUI [1])
medical condition Significant Increase Complication of surgical procedure At risk | medical condition Uncontrolled Increase Complication of surgical procedure At risk | LABORATORY ABNORMALITIES Increase Complication of surgical procedure At risk | medical condition Significant Increase Vaccine Therapy At risk | medical condition Uncontrolled Increase Vaccine Therapy At risk | LABORATORY ABNORMALITIES Increase Vaccine Therapy At risk
Item
significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
boolean
C3843040 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0274311 (UMLS CUI [1,4])
C1444641 (UMLS CUI [1,5])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0442805 (UMLS CUI [2,3])
C0274311 (UMLS CUI [2,4])
C1444641 (UMLS CUI [2,5])
C1853129 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
C0274311 (UMLS CUI [3,3])
C1444641 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C0042209 (UMLS CUI [4,4])
C1444641 (UMLS CUI [4,5])
C3843040 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0442805 (UMLS CUI [5,3])
C0042209 (UMLS CUI [5,4])
C1444641 (UMLS CUI [5,5])
C1853129 (UMLS CUI [6,1])
C0442805 (UMLS CUI [6,2])
C0042209 (UMLS CUI [6,3])
C1444641 (UMLS CUI [6,4])
gene therapy | Therapeutic procedure Based Adenoviral
Item
previous treatment with gene therapy (including any adenoviral-based therapy)
boolean
C0017296 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1705938 (UMLS CUI [2,2])
C0001483 (UMLS CUI [2,3])
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