Clinical trial NCT06535451: Lung Cancer Screening Program in Mexico
Official title: Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals: Experience in Mexico
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Lung cancer screening
Early detection
Lung cancer
Low-dose CT
High-risk population
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican population aged over 50 years with lung cancer risk factors

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.

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).

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

Primary outcomes:
measure: Lung cancer incidence in Mexican population
timeFrame: Annually over 3-year from inclusion
Secondary outcomes:
measure: Lung cancer survival
timeFrame: 10-year follow-up or death from lung cancer
measure: All-cause mortality
timeFrame: 10-year follow-up or death from lung cancer
Other outcomes:
measure: Lung cancer clinical stage
timeFrame: Annually over 3-year from inclusion
measure: Serum immunological biomarkers
timeFrame: Annually over 3-year from inclusion
measure: Nodule detection rate
timeFrame: Annually over 3-year from inclusion
measure: Chronic Obstructive Pulmonary disease (COPD) incidence rate
timeFrame: Annually over 3-year from inclusion
measure: Anxiety/Depression rate
timeFrame: Annually over 3-year from inclusion
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia (INCan) Mexico
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Cancerologia (INCan) Mexico
name: Oscar G Arrieta, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.