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Methylated Biomarkers of Smoking as a Selection Tool in Participants for Lung Cancer Screening (MET-SELS)

3 juni 2026 bijgewerkt door: University Hospital, Antwerp

The MET-SELS study aims to revolutionize how we identify individuals for lung cancer screening by moving beyond the limitations of self-reported smoking history. Currently, eligibility for low-dose CT (LDCT) scans relies on "pack-years"-a metric often compromised by recall bias, under-reporting, and an inability to account for the biological nuances of smoke inhalation or environmental exposure. Consequently, current criteria miss nearly half of incidental lung cancers.

To bridge this gap, the study investigates DNA methylation as a stable, objective "biological footprint" of smoking. Unlike short-term biomarkers like nicotine or CO levels, specific epigenetic changes in genes such as AHRR and F2RL3 persist long after cessation and correlate accurately with cumulative tobacco exposure.

Led by Professor Dr. Annemiek Snoeckx and a multidisciplinary team at UZA and the Centre for Medical Genetics, the research will analyze saliva samples from two groups: roughly 900 participants from the ZORALCS screening trial and 150 volunteers. By comparing saliva-derived genomic signatures against both self-reported data and professional interviews, the team aims to validate a panel of methylation markers that can pinpoint high-risk individuals with far greater precision.

The ultimate vision for MET-SELS is to implement a population-based "saliva-first" triage system, similar to the FIT test used for colorectal cancer. In this model, high-risk candidates would provide a saliva sample at home; only those with a confirmed epigenetic risk profile would be invited for a LDCT scan, significantly increasing the yield of early-stage lung cancer detection while streamlining healthcare resources.

Studie Overzicht

Gedetailleerde beschrijving

The MET-SELS study represents a sophisticated paradigm shift in oncology and preventive medicine, aiming to solve one of the most persistent challenges in lung cancer screening (LCS): the accurate identification of the high-risk population. Currently, global screening protocols-which rely on low-dose CT (LDCT) scans-target individuals based on "categorical smoking criteria," typically defined by age and a history of at least 30 pack-years. However, as the MET-SELS researchers argue, these criteria are fundamentally flawed. They are largely arbitrary, susceptible to significant recall and volunteer bias, and fail to capture the biological reality of smoking behavior, such as inhalation depth, nicotine retention, or the compounding effects of second-hand smoke. Because current methods only capture approximately 50% of incidental lung cancers, there is a critical need for a "bias-proof" and biologically grounded selection tool.

To address this, the study, led by Principal Investigator Professor Dr. Annemiek Snoeckx and a multidisciplinary team including Professors Ken Op de Beeck, Guy Van Camp, and Jan van Meerbeeck, turns to the cutting-edge field of epigenetics. The central hypothesis is that tobacco smoke leaves a permanent and quantifiable "molecular scar" on the human genome through DNA methylation. While traditional biomarkers like carbon monoxide in exhaled breath or cotinine in serum only reflect short-term nicotine exposure-and can be easily masked by temporary abstinence or nicotine replacement therapy-DNA methylation patterns in specific genes are remarkably robust. Specifically, the study focuses on a panel of genes including AHRR, F2RL3, and ALPPL2. Research has shown that people who smoke or used to smoke exhibit significantly lower methylation levels at the AHRR site (cg05575921) compared to people who never smoked. Crucially, while some of these epigenetic markers begin to reverse upon quitting, others remain stable for more than 30 years after cessation, providing a reliable "biological ledger" of a person's lifetime tobacco exposure and their true risk profile.

The methodology of the MET-SELS study is designed for high statistical power and clinical relevance. It utilizes two distinct cohorts: Cohort 1 consists of 850-900 participants from the ZORALCS screening implementation study at UZA, and Cohort 2 includes 150 volunteers aged 50 and older, covering a spectrum of smoking histories. Participants provide a simple 2 ml saliva sample, which is far less invasive and more cost-effective for mass screening than blood-based liquid biopsies. These samples undergo rigorous genomic and methylomic analysis at the Centre for Medical Genetics, employing techniques such as whole-genome sequencing (WGS) and quantitative methylation-specific PCR (qMSP). These biological results are then cross-referenced against two types of behavioral data: self-reported questionnaires and intensive, structured interviews led by specialized healthcare providers. By using ROC analysis and linear regression, the study aims to validate how accurately these salivary biomarkers can predict smoking status, pack-years, and duration of abstinence compared to traditional reporting.

The long-term vision of MET-SELS is nothing short of a total transformation of public health policy. The researchers aim to validate a "saliva-first" triage model for lung cancer, analogous to the FIT (Fecal Immunochemical Test) used in colorectal cancer screening. In this envisioned future, a saliva collection kit would be mailed to the target-age population; only those whose epigenetic signature reveals a high-risk profile would be invited for a clinical LDCT scan. This approach would not only improve the yield of early-stage lung cancer detection but also significantly enhance the cost-effectiveness of screening programs by excluding low-risk individuals who are currently selected based on inaccurate self-reporting. By replacing subjective anecdotes with objective genomic data, the MET-SELS study paves the way for a more precise, equitable, and effective era of cancer prevention.

Studietype

Ingrijpend

Inschrijving (Geschat)

1000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Antwerpen
      • Antwerp, Antwerpen, België, 2650

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Cohort 1: Volunteers

Inclusion Criteria:

  • Age: Must be > 50 years of age
  • Smoking History: Includes individuals with and without a smoking history

Cohort 2: ZORALCS-study participants

Inclusion Criteria:

  • Age: 55-74 years old
  • Smoking History: Includes individuals with a smoking history

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort - volunteers
Reference group: people who smoked less than 10 years
Participants provide a simple 2 ml saliva sample, which is far less invasive and more cost-effective for mass screening than blood-based liquid biopsies. These samples undergo rigorous genomic and methylomic analysis at the Centre for Medical Genetics, employing techniques such as whole-genome sequencing (WGS) and quantitative methylation-specific PCR (qMSP). These biological results are then cross-referenced against two types of behavioral data: self-reported questionnaires and intensive, structured interviews led by specialized healthcare providers. By using ROC analysis and linear regression, the study aims to validate how accurately these salivary biomarkers can predict smoking status, pack-years, and duration of abstinence compared to traditional reporting.
Experimenteel: Cohort: Lung cancer screening participants
Participants of the ZORALCS-study
Participants provide a simple 2 ml saliva sample, which is far less invasive and more cost-effective for mass screening than blood-based liquid biopsies. These samples undergo rigorous genomic and methylomic analysis at the Centre for Medical Genetics, employing techniques such as whole-genome sequencing (WGS) and quantitative methylation-specific PCR (qMSP). These biological results are then cross-referenced against two types of behavioral data: self-reported questionnaires and intensive, structured interviews led by specialized healthcare providers. By using ROC analysis and linear regression, the study aims to validate how accurately these salivary biomarkers can predict smoking status, pack-years, and duration of abstinence compared to traditional reporting.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DNA-methylation
Tijdsspanne: 3 years
DNA Methylation Status, measured as a continuous variable across a panel of specific genes (e.g., AHRR, F2RL3, ALPPL2).
3 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comparative smoking accuracy
Tijdsspanne: 2 years
Self-reported vs. Interview-based Accuracy: Comparing how well the DNA markers correlate with the participant's own questionnaire answers versus the data gathered by a specialized healthcare professional
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Annemiek Snoeckx, MD, PhD, University Of Antwerp / Antwerp University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 oktober 2025

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 4607 (Andere identificatie: Antwerp University Hospital)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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