ID

36438

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

May 14, 2019

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]
C4282132
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
C4282132 (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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