Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
Healthy Volunteers
ID05724264

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

Led by National Cancer Centre, Singapore · Updated on 2025-01-08

1000

Participants Needed

3

Research Sites

388 weeks

Total Duration

On this page

Sponsors

N

National Cancer Centre, Singapore

Lead Sponsor

S

Singapore General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of using low dose CT (LDCT) screening combined with biomarker testing to detect lung cancer in at-risk populations in Singapore. This single arm cohort study focuses on both smokers and non-smokers who have risk factors such as family history of lung cancer. The goal is to understand how well LDCT screening can be implemented locally and to gather baseline data especially for lung adenocarcinoma in never-smokers, a group unique to East Asia. The study follows guidelines from the Academy of Medicine, Singapore and uses Lung CT Screening Reporting & Data System (Lung-RADS) to report results. Participants will undergo LDCT scans and provide blood samples for biomarker assays at each screening visit. Additional samples such as urine, saliva, and breath may also be collected. Based on the Lung-RADS score assigned from the scan results, participants will be grouped and managed accordingly. Those with scores of 2 or higher will be referred for further follow-up and clinical evaluation up to five years, while those with a score of 1 will be monitored with screening surveillance ending after two years if no nodules are found. During the study, detailed information on participants’ demographics, smoking history, environmental exposures, family history, tuberculosis history, and comorbidities will be collected. Participants will be monitored through scans, blood draws, and other sample collections over the study period. Researchers will measure the feasibility of LDCT screening at baseline and up to two years afterward while providing clinical surveillance and management for participants with suspicious findings. The total age range for participation is 50 to 80 years, with a target of 650 non-smokers and 350 smokers.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is willing and able to give informed consent for participation in the study
  • Male or female, aged 50-80 years
  • No prior history of cancer, or cancer free in the last 5 years and not currently on cancer treatment
  • ECOG performance status 0 or 1
  • Willing to comply with study follow-up schedule and tests
  • Willing to cover costs of standard care management including doctor's fees, CT scans, and biopsies
  • A Singapore citizen or Permanent Resident of Singapore
  • Current or former smokers with at least 30 pack years of smoking history (for smoker group)
  • Never smokers or those who smoked less than 10 pack-years and quit smoking for at least 15 years with family history of lung cancer up to 2nd degree relatives (for non-smoker group)
Not Eligible

You will not qualify if you...

  • Uncontrolled medical comorbidities at enrollment
  • Previous diagnosis of cancer
  • Bleeding disorders that prevent blood sampling
  • Fear of blood draws or needles
  • Pregnancy

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Trial Site Locations

Total: 3 locations

1

National Cancer Centre, Singapore

Singapore, Singapore, 168583

Actively Recruiting

2

Singapore General Hospital

Singapore, Singapore, 169608

Actively Recruiting

3

National Heart Centre Singapore

Singapore, Singapore, 169609

Actively Recruiting

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Research Team

D

Darren Wan-Teck Lim, MD

G

Gillianne Geet-Yi Lai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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