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Recruiting NCT06535451

Lung Cancer Screening Program in Mexico

Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screening.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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).

Primary outcome measures

  • Lung cancer incidence in Mexican population [Time frame: Annually over 3-year from inclusion]
Secondary outcome measures (2)
  • Lung cancer survival [Time frame: 10-year follow-up or death from lung cancer]
  • All-cause mortality [Time frame: 10-year follow-up or death from lung cancer]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Mexico · 1 center
  • Instituto Nacional de Cancerologia (INCan) Mexico — Mexico City

Publications

  • 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
  • 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
  • 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- PMID 36130340
  • 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
  • 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

Identifiers

NCT: NCT06535451 · (015/005/ICI)(CEI 946/15)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗