Lung Cancer Screening Program in Mexico

NCT06535451 | Recruiting

• 1 other identifier: (015/005/ICI)(CEI 946/15)
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung cancer screening; Early detection; Lung cancer; Low-dose CT; High-risk population

Outcome Measures

Primary Outcomes (1)

• Lung cancer incidence in Mexican population

  Assess the number of lung cancer detections after each round of screening.

  Annually over 3-year from inclusion

Secondary Outcomes (2)

• Lung cancer survival

  10-year follow-up or death from lung cancer

• All-cause mortality

  10-year follow-up or death from lung cancer

Other Outcomes (5)

• Lung cancer clinical stage

  Annually over 3-year from inclusion

• Serum immunological biomarkers

  Annually over 3-year from inclusion

• Nodule detection rate

  Annually over 3-year from inclusion

Study Arms (1)

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

Interventions

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).

Screening

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mexican population aged over 50 years with lung cancer risk factors

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia (INCan) Mexico

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (5)

• Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.

  PMID: 8080679 BACKGROUND

• Arroyo-Hernandez M, Maldonado F, Lozano-Ruiz F, Munoz-Montano W, Nunez-Baez M, Arrieta O. Radiation-induced lung injury: current evidence. BMC Pulm Med. 2021 Jan 6;21(1):9. doi: 10.1186/s12890-020-01376-4.

  PMID: 33407290 BACKGROUND

• Arroyo-Hernandez M, Alva-Lopez LF, Rendon A, Barroso-Villafuerte FR, Baez-Saldana R, Corona-Cruz JF, Farfan-Salazar G, Guerrero-Ixtlahuac J, Castillo-Gonzalez P, Salmon-Demongin A, Zaldivar-Crosby G, Bolano-Guerra LM, Zavala-Cruz GG, Sanchez-Gutierrez A, Rendon-Ramirez EJ, Magdaleno-Maldonado GE, Olivares-Torres CA, Lopez-Saucedo RA, Lizardo-Rodriguez AE, Ortiz-Vazquez S, Vazquez-Garcia J, Montes-Narvaez G, Pacheco-Juarez M, Arrieta-Rodriguez OG. Guia de Practica Clinica para el diagnostico temprano y la referencia oportuna del cancer de pulmon. Salud Publica Mex. 2022 Aug 26;64(5, sept-oct):530-538. doi: 10.21149/13919. Spanish.

  PMID: 36130340 BACKGROUND

• Arroyo-Hernandez M, Zinser-Sierra JW, Vazquez-Garcia JC. [Lung-cancer screening program in Mexico]. Salud Publica Mex. 2019 May-Jun;61(3):347-351. doi: 10.21149/10326. Spanish.

  PMID: 31276351 BACKGROUND

• Arrieta O, Arroyo-Hernandez M, Soberanis-Pina PD, Viola L, Del Re M, Russo A, de Miguel-Perez D, Cardona AF, Rolfo C. Facing an un-met need in lung cancer screening: The never smokers. Crit Rev Oncol Hematol. 2024 Oct;202:104436. doi: 10.1016/j.critrevonc.2024.104436. Epub 2024 Jul 6.

  PMID: 38977146 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Oscar G Arrieta, M.D., M.Sc.

  Instituto Nacional de Cancerologia (INCan) Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

5556280400; ogarrieta@gmail.com

Marisol Arroyo Hernández, M.D.

CONTACT

5556280400; marisol.neumologia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Oncology Unit

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: March 24, 2022
• Primary Completion: March 24, 2026
• Study Completion (Estimated): March 24, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)