ID

38584

Descrição

Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT01823003

Link

https://clinicaltrials.gov/show/NCT01823003

Palavras-chave

Versões (1)
  1. 25/10/2019 25/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01823003

Inglês

Eligibility Carcinoma, Non-Small-Cell Lung NCT01823003

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive pet/ct suggestive for primary tumour(suv max> 4).
Descrição

Primary malignant neoplasm of lung | Secondary malignant neoplasm of lung Due to Cancer Other | PET/CT Positive | Suggestive of Primary tumor | SUV Maximum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1306460
UMLS CUI [2,1]
C0153676
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1707251
UMLS CUI [3,1]
C1699633
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0332299
UMLS CUI [4,2]
C0677930
UMLS CUI [5,1]
C2348529
UMLS CUI [5,2]
C0806909
tumour size < 5 cm in diameter prior to treatment.
Descrição

Tumor size Diameter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
Descrição

Patients Inoperable | Patients Operable Refused Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C0749192
life expectancy of >12 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
criterion for medical inoperability include:
Descrição

Criterion Patients Inoperable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0205187
overall clinical assessment at the ucla thoracic tumour board. reduced pulmonary function (fev1, dlco, etc) based on one major or two minor criterion as described below: minor criteria: age > 75, fev1 51- 60% predicted, or fev1 1-1.2l, dlco 51%-60% predicted, pulmonary hypertension, poor left ventricular function (ef < 40% or less), resting or exercise arterial po2 < 55 mmhg, and pco2 > 45 mmhg.
Descrição

Clinical assessment Overall | Pulmonary function test decreased | FEV1 | Carbon Monoxide Diffusing Capability Test | Age | Percent predicted FEV1 | Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide | Pulmonary Hypertension | Left Ventricular Function Poor | Cardiac ejection fraction | Arterial partial pressure Oxygen measurement Resting | Arterial pO2 after exercise | Carbon dioxide measurement, partial pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4534461
UMLS CUI [1,2]
C1561607
UMLS CUI [2]
C0855775
UMLS CUI [3]
C0849974
UMLS CUI [4]
C1516251
UMLS CUI [5]
C0001779
UMLS CUI [6]
C0730561
UMLS CUI [7]
C4054207
UMLS CUI [8]
C0020542
UMLS CUI [9,1]
C0080310
UMLS CUI [9,2]
C0542537
UMLS CUI [10]
C0232174
UMLS CUI [11,1]
C0202155
UMLS CUI [11,2]
C0035253
UMLS CUI [12]
C2021522
UMLS CUI [13]
C0201931
age > 18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
kps > 70.
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
barthel score >40
Descrição

Barthel score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4511241
baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
Descrição

Chest CT | Pulmonary function tests | Positron-Emission Tomography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C0024119
UMLS CUI [3]
C0032743
if a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
Descrição

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
ability to understand and the willingness to sign a written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior thoracic radiation treatment wich dose contribution can be expected in the new sbrt plan.
Descrição

Radiotherapy to thorax

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4038705
more than two lesions per lobe.
Descrição

Lesion Quantity per Lobe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3887962
UMLS CUI [1,4]
C0796494
active infections requiring systemic antibiotics.
Descrição

Communicable Diseases Requirement Antibiotics for systemic use

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3540704
age <18 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
kps < 70.
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
barthel total score < 40.
Descrição

Barthel score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4511241
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01823003

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Primary malignant neoplasm of lung | Secondary malignant neoplasm of lung Due to Cancer Other | PET/CT Positive | Suggestive of Primary tumor | SUV Maximum
Item
histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive pet/ct suggestive for primary tumour(suv max> 4).
boolean
C1306460 (UMLS CUI [1])
C0153676 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1707251 (UMLS CUI [2,3])
C1699633 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0332299 (UMLS CUI [4,1])
C0677930 (UMLS CUI [4,2])
C2348529 (UMLS CUI [5,1])
C0806909 (UMLS CUI [5,2])
Tumor size Diameter
Item
tumour size < 5 cm in diameter prior to treatment.
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Patients Inoperable | Patients Operable Refused Surgery
Item
medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
boolean
C0030705 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0749192 (UMLS CUI [2,3])
Life Expectancy
Item
life expectancy of >12 months.
boolean
C0023671 (UMLS CUI [1])
Criterion Patients Inoperable
Item
criterion for medical inoperability include:
boolean
C0243161 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
Clinical assessment Overall | Pulmonary function test decreased | FEV1 | Carbon Monoxide Diffusing Capability Test | Age | Percent predicted FEV1 | Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide | Pulmonary Hypertension | Left Ventricular Function Poor | Cardiac ejection fraction | Arterial partial pressure Oxygen measurement Resting | Arterial pO2 after exercise | Carbon dioxide measurement, partial pressure
Item
overall clinical assessment at the ucla thoracic tumour board. reduced pulmonary function (fev1, dlco, etc) based on one major or two minor criterion as described below: minor criteria: age > 75, fev1 51- 60% predicted, or fev1 1-1.2l, dlco 51%-60% predicted, pulmonary hypertension, poor left ventricular function (ef < 40% or less), resting or exercise arterial po2 < 55 mmhg, and pco2 > 45 mmhg.
boolean
C4534461 (UMLS CUI [1,1])
C1561607 (UMLS CUI [1,2])
C0855775 (UMLS CUI [2])
C0849974 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0730561 (UMLS CUI [6])
C4054207 (UMLS CUI [7])
C0020542 (UMLS CUI [8])
C0080310 (UMLS CUI [9,1])
C0542537 (UMLS CUI [9,2])
C0232174 (UMLS CUI [10])
C0202155 (UMLS CUI [11,1])
C0035253 (UMLS CUI [11,2])
C2021522 (UMLS CUI [12])
C0201931 (UMLS CUI [13])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps > 70.
boolean
C0206065 (UMLS CUI [1])
Barthel score
Item
barthel score >40
boolean
C4511241 (UMLS CUI [1])
Chest CT | Pulmonary function tests | Positron-Emission Tomography
Item
baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
boolean
C0202823 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
if a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to thorax
Item
prior thoracic radiation treatment wich dose contribution can be expected in the new sbrt plan.
boolean
C4038705 (UMLS CUI [1])
Lesion Quantity per Lobe
Item
more than two lesions per lobe.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3887962 (UMLS CUI [1,3])
C0796494 (UMLS CUI [1,4])
Communicable Diseases Requirement Antibiotics for systemic use
Item
active infections requiring systemic antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3540704 (UMLS CUI [1,3])
Age
Item
age <18 years old.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps < 70.
boolean
C0206065 (UMLS CUI [1])
Barthel score
Item
barthel total score < 40.
boolean
C4511241 (UMLS CUI [1])
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