Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376097
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-17
Brief Title:
Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Implementation of a Lung Cancer Screening Program in a Public Service Using Low-dose Tomography and Metabolomics Evaluation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service
Detailed Description:
Patients clinical data recruited from the outpatient clinics and wards of Hospital das Clínicas from the Faculty of Medicine of Botucatu will be collected in a specific form developed to this work containing the following data demographic characteristics name age sex race profession marital status monthly income and education main diagnosis and diseases associated assessment of comorbidities using the Charlson Index and Hospital Health Scale
Anxiety and Depression HAD Scale use of maintenance medications history of smoking active or not calculation of smoking load body composition mass index body- BMI calculation and pulse oximetry measurement All patients included will undergo low-dose radiation tomography and spirometry All patients active smokers who wish to stop smoking will be referred to the outpatient clinic smoking cessation Specific measurements will be applied if there is a diagnosis of COPD by spirometry the BODE Index questionnaires Dyspnea Index-Medical Modified Research Council TC6 and patients will be referred to the outpatient clinic specific COPD for follow-up in the service Subsequently the anxiety and depression assessments The tracking protocol will follow the recommendations of repeat the low-dose radiation chest tomography every year if normal until complete two years of follow-up In this case the patient will be discharged from the tracking If the patient presents changes in the tomography follow-up protocol according to the size of the lesions will be carried out Morbidity and mortality assessment will be carried out in patients diagnosed with lung cancer
Anxiety and Depression HAD Scale use of maintenance medications history of smoking active or not calculation of smoking load body composition mass index body- BMI calculation and pulse oximetry measurement All patients included will undergo low-dose radiation tomography and spirometry All patients active smokers who wish to stop smoking will be referred to the outpatient clinic smoking cessation Specific measurements will be applied if there is a diagnosis of COPD by spirometry the BODE Index questionnaires Dyspnea Index-Medical Modified Research Council TC6 and patients will be referred to the outpatient clinic specific COPD for follow-up in the service Subsequently the anxiety and depression assessments The tracking protocol will follow the recommendations of repeat the low-dose radiation chest tomography every year if normal until complete two years of follow-up In this case the patient will be discharged from the tracking If the patient presents changes in the tomography follow-up protocol according to the size of the lesions will be carried out Morbidity and mortality assessment will be carried out in patients diagnosed with lung cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None