ID

18545

Beskrivning

PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT00136890

Länk

https://clinicaltrials.gov/show/NCT00136890

Nyckelord

Versioner (1)
  1. 2016-11-10 2016-11-10 -
Uppladdad den

10 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small-cell Lung Carcinoma NCT00136890

Engelsk

Eligibility Non-small-cell Lung Carcinoma NCT00136890

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological proof of nsclc
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
stage i, ii, or iiia nsclc based upon clinical staging
Beskrivning

TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
the primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (cxr) and ct thorax.
Beskrivning

Primary Lesion Appropriate Excision | Plain chest X-ray | Chest CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1402294
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0728940
UMLS CUI [2]
C0039985
UMLS CUI [3]
C0202823
age over 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (fev1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon monoxide (dlco) < 40% predicted
Beskrivning

Pulmonary function Poor Excludes Operative Surgical Procedures Radical | Mature Neutrophils Lung Inadequate Operative Surgical Procedures Radical | FEV1 Post Excision | Carbon Monoxide Diffusing Capability Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0543467
UMLS CUI [1,5]
C0439807
UMLS CUI [2,1]
C1708947
UMLS CUI [2,2]
C0024109
UMLS CUI [2,3]
C0205412
UMLS CUI [2,4]
C0543467
UMLS CUI [2,5]
C0439807
UMLS CUI [3,1]
C0748133
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0728940
UMLS CUI [4]
C1516251
poor performance status (eastern cooperative oncology group [ecog] 3-4)
Beskrivning

ECOG performance status Poor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0542537
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
Beskrivning

Medical Problem Significant | Diabetic - poor control | cardiac problem | Chronic Obstructive Airway Disease Significant | Patient unfit Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0262402
UMLS CUI [4,1]
C0024117
UMLS CUI [4,2]
C0750502
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C3841806
UMLS CUI [5,3]
C0543467
pregnant or lactating females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to lie supine for imaging with pet
Beskrivning

Positron-Emission Tomography Supine Position Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C1299582
patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
Beskrivning

Malignant Neoplasm Treated | Skin carcinoma | Carcinoma in situ of uterine cervix | Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332296
patients who, at the time of the initial evaluation, have already undergone a whole body pet/pet-ct, ct brain, mri brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomization will be excluded. however, patients who have had a ct scan of the thorax with abdomen are not excluded.
Beskrivning

Whole body Positron-Emission Tomography | Whole body PET/CT scan | CAT scan of brain | MRI brain procedure | Whole body Radioisotope scan of bone | Mediastinoscopy | CT of chest and abdomen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0444584
UMLS CUI [1,2]
C0032743
UMLS CUI [2,1]
C0444584
UMLS CUI [2,2]
C1699633
UMLS CUI [3]
C0412585
UMLS CUI [4]
C0412675
UMLS CUI [5,1]
C0444584
UMLS CUI [5,2]
C0203668
UMLS CUI [6]
C0025065
UMLS CUI [7]
C1630402
failure to provide informed consent
Beskrivning

Informed Consent failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Non-small-cell Lung Carcinoma NCT00136890

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histological or cytological proof of nsclc
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
stage i, ii, or iiia nsclc based upon clinical staging
boolean
C3258246 (UMLS CUI [1])
Primary Lesion Appropriate Excision | Plain chest X-ray | Chest CT
Item
the primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (cxr) and ct thorax.
boolean
C1402294 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0039985 (UMLS CUI [2])
C0202823 (UMLS CUI [3])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pulmonary function Poor Excludes Operative Surgical Procedures Radical | Mature Neutrophils Lung Inadequate Operative Surgical Procedures Radical | FEV1 Post Excision | Carbon Monoxide Diffusing Capability Test
Item
poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (fev1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon monoxide (dlco) < 40% predicted
boolean
C0231921 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0439807 (UMLS CUI [1,5])
C1708947 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
C0439807 (UMLS CUI [2,5])
C0748133 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0728940 (UMLS CUI [3,3])
C1516251 (UMLS CUI [4])
ECOG performance status Poor
Item
poor performance status (eastern cooperative oncology group [ecog] 3-4)
boolean
C1520224 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
Medical Problem Significant | Diabetic - poor control | cardiac problem | Chronic Obstructive Airway Disease Significant | Patient unfit Operative Surgical Procedures
Item
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
boolean
C1254481 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0262402 (UMLS CUI [3])
C0024117 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0030705 (UMLS CUI [5,1])
C3841806 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Positron-Emission Tomography Supine Position Unable
Item
unable to lie supine for imaging with pet
boolean
C0032743 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Malignant Neoplasm Treated | Skin carcinoma | Carcinoma in situ of uterine cervix | Disease Free of
Item
patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
Whole body Positron-Emission Tomography | Whole body PET/CT scan | CAT scan of brain | MRI brain procedure | Whole body Radioisotope scan of bone | Mediastinoscopy | CT of chest and abdomen
Item
patients who, at the time of the initial evaluation, have already undergone a whole body pet/pet-ct, ct brain, mri brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomization will be excluded. however, patients who have had a ct scan of the thorax with abdomen are not excluded.
boolean
C0444584 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
C0444584 (UMLS CUI [2,1])
C1699633 (UMLS CUI [2,2])
C0412585 (UMLS CUI [3])
C0412675 (UMLS CUI [4])
C0444584 (UMLS CUI [5,1])
C0203668 (UMLS CUI [5,2])
C0025065 (UMLS CUI [6])
C1630402 (UMLS CUI [7])
Informed Consent failed
Item
failure to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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