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Trial Title:
Lung Cancer Screening Program in Mexico
NCT ID:
NCT06535451
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer screening
Early detection
Lung cancer
Low-dose CT
High-risk population
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Screening
Description:
Annual LDCT, lung function test (spirometry), anxiety/depression assessments, and serum
biomarkers tests over 3 years. Follow-up will continue for 5 and 10 years or until event
completion (cancer diagnosis, end of follow-up, or death).
Arm group label:
Screening
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 hours/year, 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).
Criteria for eligibility:
Study pop:
Mexican population aged over 50 years with lung cancer risk factors
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Eligible participants over fifty years old and one of the next criteria:
- Current smokers (>20 pack-years)
- Former smokers (>20 pack-years) who have quit within the past 15 years,
- Non-smokers exposed to wood smoke more than 100 hours/year
- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Exclusion Criteria:
- Subjects who cannot be examined by tomography due to physical limitations such as
weight.
- History of any type of cancer within the last five years, except non-melanoma skin
cancer.
- Symptoms consistent with some malignant neoplasm.
- People with a poor physical-emotional condition that reduces their life expectancy
or does not ensure adherence to the study.
Elimination Criteria
• Withdrawal of informed consent
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Instituto Nacional de Cancerologia (INCan) Mexico
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Oscar G Arrieta, M.D., M.Sc.
Phone:
5556280400
Phone ext:
44001
Email:
ogarrieta@gmail.com
Contact backup:
Last name:
Marisol Arroyo-Hernández, M.D., M.Sc.
Phone:
5556280400
Email:
marisol.neumologia@gmail.com
Start date:
March 24, 2022
Completion date:
March 24, 2027
Lead sponsor:
Agency:
Instituto Nacional de Cancerologia de Mexico
Agency class:
Other
Source:
Instituto Nacional de Cancerologia de Mexico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06535451
