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NCT Number: NCT06535451

Lung Cancer Screening Program 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Cancerologia (INCan) Mexico

Mexico City, Tlalpan, 14080, Mexico

Location status: Recruiting

Location contact

Marisol Arroyo-Hernández, M.D., M.Sc.

CONTACT

[email protected]

5556280400

Oscar G Arrieta, M.D., M.Sc.

CONTACT

[email protected]

5556280400 ext. 44001

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. Lung cancer clinical stage

    Time frame: Annually over 3-year from inclusion

    Assess stage of the disease in patients detected by LDCT screening program

  2. Serum immunological biomarkers

    Time frame: Annually over 3-year from inclusion

    Assess Inflammatory cytokines

  3. Nodule detection rate

    Time frame: Annually over 3-year from inclusion

    Assess nodule detection rate, characteristics and outcomes detected at the screening protocol.

  4. 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

  5. Anxiety/Depression rate

    Time frame: Annually over 3-year from inclusion

    Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program.

Study contacts

Contact information is provided by the study sponsor or research team.

Marisol Arroyo Hernández, M.D.

CONTACT

[email protected]

5556280400

Oscar G Arrieta, M.D., M.Sc.

CONTACT

[email protected]

5556280400 ext. 44001

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

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

Acronym: DETECTO

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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