Lung CancerDETECTONCT06535451
Lung Cancer Screening Program in Mexico
An observational study of Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Screening
- How many people
- 1,000 participants
- Where
- 1 siteMexico
- Study dates
- 24 Mar 2022to 24 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mexican population aged over 50 years with lung cancer risk factors
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerologia (INCan) Mexico
Mexico City, Tlalpan, 14080
Oscar G Arrieta, M.D., M.Sc., 5556280400 ext. 44001, ogarrieta@gmail.com
Marisol Arroyo-Hernández, M.D., M.Sc., 5556280400, marisol.neumologia@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Lung Cancer
- Being tested
- Screening
- Keywords
- Lung cancer screening, Early detection, Lung cancer, Low-dose CT, High-risk population
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer incidence in Mexican population
Assess the number of lung cancer detections after each round of screening.
Measured: Annually over 3-year from inclusion
Secondary outcomes (2)
Lung cancer survival
Assess lung cancer mortality in participants included in the screening protocol and outside the protocol.
Measured: 10-year follow-up or death from lung cancer
All-cause mortality
Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up
Measured: 10-year follow-up or death from lung cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start24 Mar 2022
- Primary completion24 Mar 2026 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar G Arrieta, M.D., M.Sc., Principal investigator, Instituto Nacional de Cancerologia (INCan) Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535451
- Sponsor's protocol ID
- (015/005/ICI)(CEI 946/15)
- Acronym
- DETECTO
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 8080679Arroyo-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.
PubMed 33407290Arroyo-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.
PubMed 36130340Arroyo-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.
PubMed 31276351Arrieta 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.
PubMed 38977146
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals: Experience in Mexico
- ClinicalTrials.gov ID
- NCT06535451
- Acronym / sponsor ID
- DETECTO / (015/005/ICI)(CEI 946/15)
- Conditions
- Lung Cancer
- Keywords
- Lung cancer screening, Early detection, Lung cancer, Low-dose CT, High-risk population
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 24 Mar 2026 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Other: ScreeningCurrent 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican population aged over 50 years with lung cancer risk factors
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningAnnual 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). | Other | Screening |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 8080679Bergman 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.
- Background: PubMed 33407290Arroyo-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.
- Background: PubMed 36130340Arroyo-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.
- Background: PubMed 31276351Arroyo-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.
- Background: PubMed 38977146Arrieta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar G Arrieta, M.D., M.Sc. principal investigator
Instituto Nacional de Cancerologia (INCan) Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar G Arrieta, M.D., M.Sc. (5556280400 ext. 44001, ogarrieta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer incidence in Mexican population (time frame: Annually over 3-year from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535451, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.