ID

36608

Description

Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02256852

Link

https://clinicaltrials.gov/show/NCT02256852

Keywords

  1. 5/26/19 5/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 26, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT02256852

Eligibility Non-Small Cell Lung Cancer NCT02256852

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female who is at or above the age of consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed original diagnosis of lung cancer
Description

Carcinoma of lung

Data type

boolean

Alias
UMLS CUI [1]
C0684249
life expectancy greater than 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0, 1, or 2 at screening
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
Description

Gender Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug
Description

Gender Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extra-thoracic lung cancer progression
Description

Carcinoma of lung Progression | Exception Thoracic region

Data type

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C0242656
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0817096
any active malignancies
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any uncontrolled or major organ dysfunction
Description

Organ dysfunction Uncontrolled | Dysfunction Organ Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0205164
any past or current radiation or systemic therapies for the treatment of lung cancer
Description

Therapeutic radiology procedure Carcinoma of lung | Systemic therapy Carcinoma of lung

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0684249
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0684249
known hiv infection or other immunosuppressive disorder
Description

HIV Infection | Immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C4048329
concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
Description

Study Subject Participation Status | Immunotherapy Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C1517586

Similar models

Eligibility Non-Small Cell Lung Cancer NCT02256852

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female who is at or above the age of consent
boolean
C0001779 (UMLS CUI [1])
Carcinoma of lung
Item
histologically confirmed original diagnosis of lung cancer
boolean
C0684249 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1, or 2 at screening
boolean
C1520224 (UMLS CUI [1])
Gender Contraceptive methods Quantity
Item
female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Gender Barrier Contraception
Item
male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Carcinoma of lung Progression | Exception Thoracic region
Item
extra-thoracic lung cancer progression
boolean
C0684249 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
Malignant Neoplasms
Item
any active malignancies
boolean
C0006826 (UMLS CUI [1])
Organ dysfunction Uncontrolled | Dysfunction Organ Major
Item
any uncontrolled or major organ dysfunction
boolean
C0349410 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
Therapeutic radiology procedure Carcinoma of lung | Systemic therapy Carcinoma of lung
Item
any past or current radiation or systemic therapies for the treatment of lung cancer
boolean
C1522449 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0684249 (UMLS CUI [2,2])
HIV Infection | Immunosuppression
Item
known hiv infection or other immunosuppressive disorder
boolean
C0019693 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
Study Subject Participation Status | Immunotherapy Investigational
Item
concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
boolean
C2348568 (UMLS CUI [1])
C0021083 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])

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