Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
Healthy Volunteers
ID07631624

Methylated Biomarkers of Smoking as a Selection Tool in Participants for Lung Cancer Screening

Led by University Hospital, Antwerp · Updated on 2026-06-08

1000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

U

Universiteit Antwerpen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new way to improve lung cancer screening by using DNA methylation markers found in saliva. Current screening relies on self-reported smoking history, which can be inaccurate due to recall bias and under-reporting, causing many lung cancers to be missed. This study focuses on stable epigenetic changes in genes like AHRR and F2RL3 as a reliable biological record of tobacco exposure, aiming to better identify individuals at high risk for lung cancer. Participants provide a small saliva sample that undergoes detailed genetic and methylation analysis using advanced techniques like whole-genome sequencing and methylation-specific PCR. The study compares these biological results with self-reported smoking data and professional interviews. Two groups are involved: about 900 participants from a lung cancer screening trial and 150 volunteers aged 50 and older, including those with and without a history of smoking. During the study, saliva samples are collected and analyzed at a specialized genetics center. Researchers evaluate how well these markers predict smoking status and exposure length compared to traditional methods. The main outcome is DNA methylation measured over three years. The ultimate goal is to develop a saliva-based test to screen for lung cancer risk, allowing only high-risk individuals to receive low-dose CT scans. This approach could enhance early detection and make screening more efficient and cost-effective.

CONDITIONS

Brief Title

Methylated Biomarkers of Smoking as a Selection Tool in Participants for Lung Cancer Screening

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For volunteers: age over 50 years
  • Volunteers may have a smoking history or no smoking history
  • For ZORALCS-study participants: age between 55 and 74 years
  • ZORALCS participants must have a smoking history
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 3 years

Participants provide a saliva sample and complete questionnaires and interviews for epigenetic and behavioral analysis to assess smoking exposure and risk.

Periodic sample collections and interviews over the study period

Trial Site Locations

Total: 1 location

1

Antwerp University Hospital

Antwerp, Antwerpen, Belgium, 2650

Actively Recruiting

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Research Team

C

Charlotte Theuns

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

2

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