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ID

44334

Description

Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers; ODM derived from: https://clinicaltrials.gov/show/NCT00020878 Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

Link

https://clinicaltrials.gov/show/NCT00020878

Keywords

Versions (2)
  1. 5/14/19 5/14/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Jonsson Comprehensive Cancer Center

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    Celecoxib in Preventing NSCLC NCT00020878

    English

    Eligibility Criteria

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Is the participant older than 45 years of age?
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Has the participant smoked more than 20 pack years?
    Description

    Pack Years

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1277691
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Is the participant concurrently using NSAIDs?
    Description

    Concurrent NSAID use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4060806
    UMLS CUI [1,2]
    C0003211
    Does the participant have hypersensitivity to celecoxib?
    Description

    Celecoxib hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0538927
    Does the participant have a documented allergic-type reaction to sulfonamides?
    Description

    Sulfonamide allergy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301725
    UMLS CUI [1,2]
    C1527304
    UMLS CUI [1,3]
    C0038760
    Does the participant have a history of allergic reaction, urticaria or asthma to aspirin or other NSAIDs?
    Description

    Hypersensitivity reaction to aspiring or NSAIDs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1527304
    UMLS CUI [1,3]
    C0004057
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0042109
    UMLS CUI [2,3]
    C0004057
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0004096
    UMLS CUI [3,3]
    C0004057
    UMLS CUI [4,1]
    C0262926
    UMLS CUI [4,2]
    C1527304
    UMLS CUI [4,3]
    C0003211
    UMLS CUI [5,1]
    C0262926
    UMLS CUI [5,2]
    C0042109
    UMLS CUI [5,3]
    C0003211
    UMLS CUI [6,1]
    C0262926
    UMLS CUI [6,2]
    C0004096
    UMLS CUI [6,3]
    C0003211
    Does the participant have a history of liver dysfunction?
    Description

    Liver dysfunction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0086565
    Does the participant have hypertension or cardiac conditions aggravated by fluid retention and edema?
    Description

    Fluid retention problems

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538
    UMLS CUI [1,2]
    C0436331
    UMLS CUI [1,3]
    C0268000
    UMLS CUI [1,4]
    C0013604
    UMLS CUI [2,1]
    C0262402
    UMLS CUI [2,2]
    C0436331
    UMLS CUI [2,3]
    C0268000
    UMLS CUI [2,4]
    C0013604
    Does the participant have a previous history of gastrointestinal ulceration, bleeding, or perforation?
    Description

    Gastrointestinal ulcer complications

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0237938
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0017181
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0151664
    Does the participant have renal dysfunction?
    Description

    Renal dysfunction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3279454
    Does the participant have end stage respiratory disease?
    Description

    End-stage Respiratory Disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205088
    UMLS CUI [1,2]
    C0035204
    Does the participant have unstable angina?
    Description

    Unstable Angina

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    Does the participant have any other malignancy?
    Description

    Other malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    Is the participant pregnant?
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    Does the participant have a concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2c9 and 2d6 enzymes?
    Description

    Cytochrom system interference

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4060806
    UMLS CUI [1,2]
    C1515926
    UMLS CUI [1,3]
    C0608437
    UMLS CUI [1,4]
    C0057223
    Does the patient have concurrent medical conditions that may interfere with completion of tests, therapy, or the follow-up schedule?
    Description

    Interfering Medical Conditions

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205476
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C0205197
    UMLS CUI [1,5]
    C0039593
    UMLS CUI [2,1]
    C0205476
    UMLS CUI [2,2]
    C0348080
    UMLS CUI [2,3]
    C0521102
    UMLS CUI [2,4]
    C0205197
    UMLS CUI [2,5]
    C0087111
    UMLS CUI [3,1]
    C0205476
    UMLS CUI [3,2]
    C0348080
    UMLS CUI [3,3]
    C0521102
    UMLS CUI [3,4]
    C0205197
    UMLS CUI [3,5]
    C1522577
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    Similar models

    Eligibility Criteria

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    Is the participant older than 45 years of age?
    boolean
    C0001779 (UMLS CUI [1])
    Pack Years
    Item
    Has the participant smoked more than 20 pack years?
    boolean
    C1277691 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Concurrent NSAID use
    Item
    Is the participant concurrently using NSAIDs?
    boolean
    C4060806 (UMLS CUI [1,1])
    C0003211 (UMLS CUI [1,2])
    Celecoxib hypersensitivity
    Item
    Does the participant have hypersensitivity to celecoxib?
    boolean
    C0020517 (UMLS CUI [1,1])
    C0538927 (UMLS CUI [1,2])
    Sulfonamide allergy
    Item
    Does the participant have a documented allergic-type reaction to sulfonamides?
    boolean
    C1301725 (UMLS CUI [1,1])
    C1527304 (UMLS CUI [1,2])
    C0038760 (UMLS CUI [1,3])
    Hypersensitivity reaction to aspiring or NSAIDs
    Item
    Does the participant have a history of allergic reaction, urticaria or asthma to aspirin or other NSAIDs?
    boolean
    C0262926 (UMLS CUI [1,1])
    C1527304 (UMLS CUI [1,2])
    C0004057 (UMLS CUI [1,3])
    C0262926 (UMLS CUI [2,1])
    C0042109 (UMLS CUI [2,2])
    C0004057 (UMLS CUI [2,3])
    C0262926 (UMLS CUI [3,1])
    C0004096 (UMLS CUI [3,2])
    C0004057 (UMLS CUI [3,3])
    C0262926 (UMLS CUI [4,1])
    C1527304 (UMLS CUI [4,2])
    C0003211 (UMLS CUI [4,3])
    C0262926 (UMLS CUI [5,1])
    C0042109 (UMLS CUI [5,2])
    C0003211 (UMLS CUI [5,3])
    C0262926 (UMLS CUI [6,1])
    C0004096 (UMLS CUI [6,2])
    C0003211 (UMLS CUI [6,3])
    Liver dysfunction
    Item
    Does the participant have a history of liver dysfunction?
    boolean
    C0262926 (UMLS CUI [1,1])
    C0086565 (UMLS CUI [1,2])
    Fluid retention problems
    Item
    Does the participant have hypertension or cardiac conditions aggravated by fluid retention and edema?
    boolean
    C0020538 (UMLS CUI [1,1])
    C0436331 (UMLS CUI [1,2])
    C0268000 (UMLS CUI [1,3])
    C0013604 (UMLS CUI [1,4])
    C0262402 (UMLS CUI [2,1])
    C0436331 (UMLS CUI [2,2])
    C0268000 (UMLS CUI [2,3])
    C0013604 (UMLS CUI [2,4])
    Gastrointestinal ulcer complications
    Item
    Does the participant have a previous history of gastrointestinal ulceration, bleeding, or perforation?
    boolean
    C0262926 (UMLS CUI [1,1])
    C0237938 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [2,1])
    C0017181 (UMLS CUI [2,2])
    C0262926 (UMLS CUI [3,1])
    C0151664 (UMLS CUI [3,2])
    Renal dysfunction
    Item
    Does the participant have renal dysfunction?
    boolean
    C3279454 (UMLS CUI [1])
    End-stage Respiratory Disease
    Item
    Does the participant have end stage respiratory disease?
    boolean
    C0205088 (UMLS CUI [1,1])
    C0035204 (UMLS CUI [1,2])
    Unstable Angina
    Item
    Does the participant have unstable angina?
    boolean
    C0002965 (UMLS CUI [1])
    Other malignancy
    Item
    Does the participant have any other malignancy?
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Pregnancy
    Item
    Is the participant pregnant?
    boolean
    C0032961 (UMLS CUI [1])
    Cytochrom system interference
    Item
    Does the participant have a concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2c9 and 2d6 enzymes?
    boolean
    C4060806 (UMLS CUI [1,1])
    C1515926 (UMLS CUI [1,2])
    C0608437 (UMLS CUI [1,3])
    C0057223 (UMLS CUI [1,4])
    Interfering Medical Conditions
    Item
    Does the patient have concurrent medical conditions that may interfere with completion of tests, therapy, or the follow-up schedule?
    boolean
    C0205476 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C0521102 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    C0039593 (UMLS CUI [1,5])
    C0205476 (UMLS CUI [2,1])
    C0348080 (UMLS CUI [2,2])
    C0521102 (UMLS CUI [2,3])
    C0205197 (UMLS CUI [2,4])
    C0087111 (UMLS CUI [2,5])
    C0205476 (UMLS CUI [3,1])
    C0348080 (UMLS CUI [3,2])
    C0521102 (UMLS CUI [3,3])
    C0205197 (UMLS CUI [3,4])
    C1522577 (UMLS CUI [3,5])
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