ID

27416

Beskrivning

Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study); ODM derived from: https://clinicaltrials.gov/show/NCT00432640

Länk

https://clinicaltrials.gov/show/NCT00432640

Nyckelord

Versioner (1)
  1. 2017-11-14 2017-11-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00432640

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT00432640

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
consecutive patients with nsclc or with a clinical suspicion for lung cancer in whom mediastinal lymph node invasion (either n2 or n3) is suspected based on the available thoracic imaging
Beskrivning

Non-Small Cell Lung Carcinoma | Suspicion Malignant neoplasm of lung | Suspicion Tumor Invasion Mediastinal lymph nodes TNM clinical staging | Chest imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0242379
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C1269955
UMLS CUI [3,3]
C0588055
UMLS CUI [3,4]
C3258246
UMLS CUI [4]
C1531652
pending the results of the mediastinal staging, the patient is otherwise considered a candidate for a surgical treatment with the intention to cure (this is a resectable tumor)
Beskrivning

Mediastinum TNM clinical staging | Patient Appropriate Curative Surgery | Neoplasm Resectable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025066
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1511562
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1514888
the patient is clinically fit for diagnostic surgery (this is an operable patient)
Beskrivning

Physical Fitness Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031812
UMLS CUI [1,2]
C0543467
no distant metastasis after routine clinical work up
Beskrivning

Work up | Distant metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0750430
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
provision of a written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
Beskrivning

Prior Therapy Malignant neoplasm of lung | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0242379
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
reasons because of which the patient is unable to swallow the eus-instrument (e.g. zenker divertikel, unexplained esophageal stenosis) or because of which the patient is unable to undergo a bronchoscopy
Beskrivning

Endoscopic Ultrasound Unsuccessful | Zenker Diverticulum | Esophageal Stenosis Unknown | Bronchoscopy Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376443
UMLS CUI [1,2]
C1272705
UMLS CUI [2]
C0085232
UMLS CUI [3,1]
C0014866
UMLS CUI [3,2]
C0439673
UMLS CUI [4,1]
C0006290
UMLS CUI [4,2]
C1299582
patients who, based on available thoracic imaging, are unlikely to be staged accurately by any surgical staging procedure (mediastinoscopy/ - tomy, vats)
Beskrivning

Chest imaging | Mediastinoscopy Inaccurate Probably | Mediastinotomy Inaccurate Probably | VATS Inaccurate Probably

Datatyp

boolean

Alias
UMLS CUI [1]
C1531652
UMLS CUI [2,1]
C0025065
UMLS CUI [2,2]
C0443236
UMLS CUI [2,3]
C0750492
UMLS CUI [3,1]
C0198402
UMLS CUI [3,2]
C0443236
UMLS CUI [3,3]
C0750492
UMLS CUI [4,1]
C0752151
UMLS CUI [4,2]
C0443236
UMLS CUI [4,3]
C0750492
respiratory insufficiency or other contra-indications for bronchoscopy
Beskrivning

Respiratory Insufficiency | Medical contraindication Bronchoscopy

Datatyp

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0006290
concurrent other malignancies
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
uncorrected coagulopathy
Beskrivning

Blood Coagulation Disorders uncorrected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C4072785
study cannot be discussed with the patient (e.g. mental disorder)
Beskrivning

Study Protocol Discussion Unsuccessful | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0557061
UMLS CUI [1,3]
C1272705
UMLS CUI [2]
C0004936
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00432640

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Suspicion Malignant neoplasm of lung | Suspicion Tumor Invasion Mediastinal lymph nodes TNM clinical staging | Chest imaging
Item
consecutive patients with nsclc or with a clinical suspicion for lung cancer in whom mediastinal lymph node invasion (either n2 or n3) is suspected based on the available thoracic imaging
boolean
C0007131 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0242379 (UMLS CUI [2,2])
C0242114 (UMLS CUI [3,1])
C1269955 (UMLS CUI [3,2])
C0588055 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C1531652 (UMLS CUI [4])
Mediastinum TNM clinical staging | Patient Appropriate Curative Surgery | Neoplasm Resectable
Item
pending the results of the mediastinal staging, the patient is otherwise considered a candidate for a surgical treatment with the intention to cure (this is a resectable tumor)
boolean
C0025066 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1511562 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C1514888 (UMLS CUI [3,2])
Physical Fitness Operative Surgical Procedures
Item
the patient is clinically fit for diagnostic surgery (this is an operable patient)
boolean
C0031812 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Work up | Distant metastasis Absent
Item
no distant metastasis after routine clinical work up
boolean
C0750430 (UMLS CUI [1])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
provision of a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Malignant neoplasm of lung | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures
Item
former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
boolean
C1514463 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Endoscopic Ultrasound Unsuccessful | Zenker Diverticulum | Esophageal Stenosis Unknown | Bronchoscopy Unable
Item
reasons because of which the patient is unable to swallow the eus-instrument (e.g. zenker divertikel, unexplained esophageal stenosis) or because of which the patient is unable to undergo a bronchoscopy
boolean
C0376443 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0085232 (UMLS CUI [2])
C0014866 (UMLS CUI [3,1])
C0439673 (UMLS CUI [3,2])
C0006290 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Chest imaging | Mediastinoscopy Inaccurate Probably | Mediastinotomy Inaccurate Probably | VATS Inaccurate Probably
Item
patients who, based on available thoracic imaging, are unlikely to be staged accurately by any surgical staging procedure (mediastinoscopy/ - tomy, vats)
boolean
C1531652 (UMLS CUI [1])
C0025065 (UMLS CUI [2,1])
C0443236 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0198402 (UMLS CUI [3,1])
C0443236 (UMLS CUI [3,2])
C0750492 (UMLS CUI [3,3])
C0752151 (UMLS CUI [4,1])
C0443236 (UMLS CUI [4,2])
C0750492 (UMLS CUI [4,3])
Respiratory Insufficiency | Medical contraindication Bronchoscopy
Item
respiratory insufficiency or other contra-indications for bronchoscopy
boolean
C0035229 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0006290 (UMLS CUI [2,2])
Cancer Other
Item
concurrent other malignancies
boolean
C1707251 (UMLS CUI [1])
Blood Coagulation Disorders uncorrected
Item
uncorrected coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Study Protocol Discussion Unsuccessful | Mental disorders
Item
study cannot be discussed with the patient (e.g. mental disorder)
boolean
C2348563 (UMLS CUI [1,1])
C0557061 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2])
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