Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535451
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Lung Cancer Screening Program in Mexico
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals Experience in Mexico
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECTO
Brief Summary:
This prospective study aims to detect early-stage lung cancer using low-dose computed tomography LDCT in Mexicans aged 50 or older who are current or former heavy smokers non-smokers exposed to significant wood smoke or diagnosed with COPD Annual LDCT spirometry and serum biomarker tests will be conducted over 3 years and a follow-up lasting up to 10 years
Detailed Description:
This prospective cohort study aims to detect lung cancer in early stages using LDCT scans in Mexican individuals aged 50 years or older Eligible participants comprise current smokers with a history of 20 pack-years former smokers who have quit within the past 15 years non-smokers exposed to wood smoke more than 100 hoursyear or patients diagnosed with Chronic Obstructive Pulmonary Disease COPD
Secondary objectives include assessing the 10-year mortality rate the association of lung cancer with immunologic biomarkers the demographic characterization of participants the psychological impact of an LC screening program the histological profiling of positive cases lung function changes in at-risk individuals and the clinical staging distribution at diagnosis
The study will conduct annual LDCT scans lung function tests spirometry anxiety and depression assessments and serum biomarkers tests over 3 years Positive LDCT results will adhere to LUNG-RADS guidelines and be managed by a multidisciplinary team Prevention strategies including tobacco cessation treatments will be provided Follow-up will continue for 5 and 10 years or until an event of completion occurs cancer diagnosis end of follow-up or death
Secondary objectives include assessing the 10-year mortality rate the association of lung cancer with immunologic biomarkers the demographic characterization of participants the psychological impact of an LC screening program the histological profiling of positive cases lung function changes in at-risk individuals and the clinical staging distribution at diagnosis
The study will conduct annual LDCT scans lung function tests spirometry anxiety and depression assessments and serum biomarkers tests over 3 years Positive LDCT results will adhere to LUNG-RADS guidelines and be managed by a multidisciplinary team Prevention strategies including tobacco cessation treatments will be provided Follow-up will continue for 5 and 10 years or until an event of completion occurs cancer diagnosis end of follow-up or death
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