ID

21469

Description

S0424 - Carcinogens in Lung Tissue From Smokers (Closed to Entry as of 7/15/07) and Non-Smokers With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00450281

Link

https://clinicaltrials.gov/show/NCT00450281

Keywords

Versions (1)
  1. 4/23/17 4/23/17 -
Uploaded on

April 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00450281

English

Eligibility Lung Cancer NCT00450281

1 forms  
Criteria
Description

Criteria

histologically confirmed non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
stage i, ii, iiia, or iiib (t4 or n3) disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
no malignant pleural effusion; if pleural fluid is present, 1 of the following criteria must be met:
Description

Malignant Pleural Effusion Absent | Pleural fluid Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0080032
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0225778
UMLS CUI [2,2]
C0150312
benign pleural fluid
Description

Pleural fluid Benign

Data type

boolean

Alias
UMLS CUI [1,1]
C0225778
UMLS CUI [1,2]
C0205183
pleural fluid is due to prior thoracotomy
Description

Pleural fluid Due to Thoracotomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0225778
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0039991
pleural fluid is deemed too small to safely tap
Description

Pleural fluid Quantity | Pleural tap Unsuccessful Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0225778
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0189477
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C1517001
no diagnosis by cytology alone
Description

Cytology diagnosis Alone Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0332141
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C2828389
newly diagnosed disease
Description

Newly Diagnosed Disease

Data type

boolean

Alias
UMLS CUI [1]
C1334965
must have tumor blocks/slides available and must be willing to provide tissue samples
Description

Neoplasm Blocks Available | Neoplasm Slides Available | Tissue specimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1533157
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C3865498
UMLS CUI [2,3]
C0470187
UMLS CUI [3]
C1292533
prior smoking history meeting 1 of the following criteria:
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
never smoker, defined as < 100 cigarettes in lifetime
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
former smoker, defined as no smoking for ≥ 1 year
Description

Former smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337671
current smoker, defined as all others (closed to accrual as of 7/15/07)
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
no pericardial effusions
Description

Pericardial effusion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0031039
UMLS CUI [1,2]
C0332197
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
no other prior malignancy except for 1 of the following:
Description

Malignant Neoplasms Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
adequately treated basal cell or squamous cell skin cancer
Description

Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0553723
UMLS CUI [2,2]
C1522326
in situ cervical cancer
Description

Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0851140
other cancer for which the patient has been disease free for five years
Description

Malignant Neoplasm Disease Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior chemotherapy or radiotherapy
Description

Chemotherapy Absent | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
concurrent participation in therapeutic trials allowed
Description

Study Subject Participation Status | Therapeutic Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1515364
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Similar models

Eligibility Lung Cancer NCT00450281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage i, ii, iiia, or iiib (t4 or n3) disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Malignant Pleural Effusion Absent | Pleural fluid Present
Item
no malignant pleural effusion; if pleural fluid is present, 1 of the following criteria must be met:
boolean
C0080032 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0225778 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Pleural fluid Benign
Item
benign pleural fluid
boolean
C0225778 (UMLS CUI [1,1])
C0205183 (UMLS CUI [1,2])
Pleural fluid Due to Thoracotomy
Item
pleural fluid is due to prior thoracotomy
boolean
C0225778 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0039991 (UMLS CUI [1,3])
Pleural fluid Quantity | Pleural tap Unsuccessful Expected
Item
pleural fluid is deemed too small to safely tap
boolean
C0225778 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0189477 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Cytology diagnosis Alone Excluded
Item
no diagnosis by cytology alone
boolean
C0332141 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Newly Diagnosed Disease
Item
newly diagnosed disease
boolean
C1334965 (UMLS CUI [1])
Neoplasm Blocks Available | Neoplasm Slides Available | Tissue specimen
Item
must have tumor blocks/slides available and must be willing to provide tissue samples
boolean
C0027651 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C3865498 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C1292533 (UMLS CUI [3])
Tobacco use
Item
prior smoking history meeting 1 of the following criteria:
boolean
C0543414 (UMLS CUI [1])
Non-smoker
Item
never smoker, defined as < 100 cigarettes in lifetime
boolean
C0337672 (UMLS CUI [1])
Former smoker
Item
former smoker, defined as no smoking for ≥ 1 year
boolean
C0337671 (UMLS CUI [1])
Tobacco use
Item
current smoker, defined as all others (closed to accrual as of 7/15/07)
boolean
C0543414 (UMLS CUI [1])
Pericardial effusion Absent
Item
no pericardial effusions
boolean
C0031039 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Malignant Neoplasms Absent
Item
no other prior malignancy except for 1 of the following:
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
adequately treated basal cell or squamous cell skin cancer
boolean
C0007117 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0553723 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Carcinoma in situ of uterine cervix
Item
in situ cervical cancer
boolean
C0851140 (UMLS CUI [1])
Malignant Neoplasm Disease Free of
Item
other cancer for which the patient has been disease free for five years
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
no prior chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Study Subject Participation Status | Therapeutic Clinical Trial
Item
concurrent participation in therapeutic trials allowed
boolean
C2348568 (UMLS CUI [1])
C1515364 (UMLS CUI [2])
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