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.

Lien

https://clinicaltrials.gov/show/NCT00020878

Mots-clés

Versions (2)
  1. 14/05/2019 14/05/2019 -
  2. 20/09/2021 20/09/2021 -
Détendeur de droits

Jonsson Comprehensive Cancer Center

Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Celecoxib in Preventing NSCLC NCT00020878

Anglais

Eligibility Criteria

1 Formulaires  
  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

Type de données

boolean

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

Pack Years

Type de données

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

Type de données

boolean

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

Celecoxib hypersensitivity

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

End-stage Respiratory Disease

Type de données

boolean

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

Unstable Angina

Type de données

boolean

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

Other malignancy

Type de données

boolean

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

Pregnancy

Type de données

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

Type de données

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

Type de données

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 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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