Lung Cancer Screening Program in Mexico (DETECTO)

December 17, 2025 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals: Experience in Mexico

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia (INCan) Mexico
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Mexican population aged over 50 years with lung cancer risk factors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening
Current smokers (>20 pack-years) or have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Other: Screening
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer incidence in Mexican population
Time Frame: Annually over 3-year from inclusion
Assess the number of lung cancer detections after each round of screening.
Annually over 3-year from inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer survival
Time Frame: 10-year follow-up or death from lung cancer
Assess lung cancer mortality in participants included in the screening protocol and outside the protocol.
10-year follow-up or death from lung cancer
All-cause mortality
Time Frame: 10-year follow-up or death from lung cancer
Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up
10-year follow-up or death from lung cancer

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer clinical stage
Time Frame: Annually over 3-year from inclusion
Assess stage of the disease in patients detected by LDCT screening program
Annually over 3-year from inclusion
Serum immunological biomarkers
Time Frame: Annually over 3-year from inclusion
Assess Inflammatory cytokines
Annually over 3-year from inclusion
Nodule detection rate
Time Frame: Annually over 3-year from inclusion
Assess nodule detection rate, characteristics and outcomes detected at the screening protocol.
Annually over 3-year from inclusion
Chronic Obstructive Pulmonary disease (COPD) incidence rate
Time Frame: Annually over 3-year from inclusion
Detect participants with a positive spirometry test that covers COPD diagnosis
Annually over 3-year from inclusion
Anxiety/Depression rate
Time Frame: Annually over 3-year from inclusion
Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program.
Annually over 3-year from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar G Arrieta, M.D., M.Sc., Instituto Nacional de Cancerologia (INCan) Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Estimated)

March 24, 2026

Study Completion (Estimated)

March 24, 2027

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (015/005/ICI)(CEI 946/15)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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