RecruitingNot ApplicableNCT05724264

SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE)


Sponsor

National Cancer Centre, Singapore

Enrollment

1,000 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm screening study. All eligible participants will be subjected to low dose CT (LDCT) screening and biomarker testing. The primary aim of the study is to determine the feasibility of conducting LDCT screening in at-risk populations for lung cancer in Singapore: * For the smoker population, LDCT screening for lung cancer will be implemented in accordance to Academy of Medicine, Singapore screening test guidelines with the aim of investigating the feasibility of instituting lung cancer screening clinical service in Singapore. * For the non-smoker population, LDCT screening for lung cancer will be introduced to systematically collect baseline data to better understand and provide evidence for lung adenocarcinoma in never-smoker phenotype that is unique to East Asia/Singapore. This will help address unmet needs in local population research as reported by Academy of Medicine, Singapore, to validate risk factors and inform future screening guidelines for the at-risk population. Screening results will be reported based on Lung CT Screening Reporting \& Data System (Lung-RADS).


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study in Singapore is testing whether combining lung CT scans with blood-based markers (biomarkers) can improve early detection of lung cancer in people who smoke or have smoked. The goal is to find cancer earlier when it is more treatable. **You may be eligible if...** - You are 50–80 years old - You are a current or former smoker (at least 20 pack-years of smoking history) - You have no current cancer, or have been cancer-free for the past 5 years - You are generally in good health (ECOG 0 or 1) **You may NOT be eligible if...** - You are currently on cancer treatment - You have had a CT scan of your chest in the past year - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLow-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays

LDCT scan results will be reported based on the Lung-RADS classification. Participants will be stratified into various Lung-RADS groups based on the CT appearance and size of nodules. An alphanumeric Lung-RADS score will be assigned to each subject which will guide the downstream management of screened participants. All subjects will be required to donate drawn blood samples (up to 30 ml) at every LDCT visit during screening surveillance, and at every LDCT/CT scan and/or biopsy visits during clinical surveillance for blood-based biomarker assays development and characterization. Subjects may also be asked to provide a sample of urine, saliva and breath for biomarker discovery.


Locations(3)

National Cancer Centre, Singapore

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

National Heart Centre Singapore

Singapore, Singapore

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NCT05724264


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