Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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