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

NCT05724264 · tracked via the Priya Life Science Singapore tracker

Sponsor

National Cancer Centre, Singapore

Phase

Not applicable

Started

2022-07-21

Last updated

2026-05-15

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

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

Low-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.

Study 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

Sex

ALL

Min age

50 Years

Max age

80 Years

Healthy volunteers

Accepted

Inclusion Criteria: Smoker: * Participant is willing and able to give informed consent for participation in the study * Male or female, aged 50-80 years of age * No prior history of cancer, or cancer free in the last 5 years and not currently on cancer treatment * ECOG 0/1 * Current or former smokers with at least 30 pack years of smoking history * Willing to comply with study follow-up schedule and tests * Willing to cover the costs of downstream standard of care management and investigations including doctor's fee, CT scan and biopsy etc. * A Singapore citizen/Permanent Resident of Singapore Non-Smoker: * Participant is willing and able to give informed consent for participation in the study * Male, or female, aged 50-80 years of age * No prior history of cancer, or cancer free in the last 5 years and not currently on cancer treatment * ECOG 0/1 * Never smoker, or has smoked less than 10 pack-years and has quit smoking for at least 15 years * Family history of lung cancer up to 2nd degree relatives * Willing to comply with study follow-up schedule and tests * Willing to cover the costs of downstream standard of care management and investigations including doctor's fee, CT scan and biopsy etc. * A Singapore citizen/Permanent Resident of Singapore Exclusion Criteria: * Uncontrolled medical comorbidity on enrolment * Previous diagnosis of cancer * Bleeding diathesis that will preclude blood sampling * Fear of blood draw or needles * Pregnancy

Primary outcome measure(s)

Feasibility of conducting Low Dose CT (LDCT) screening in at-risk populations (1). — At Baseline.
Diagnostic accuracy of LDCT at baseline.
Feasibility of conducting LDCT screening in at-risk populations (2). — Up to 2 years after Baseline.
Compliance with LDCT screens for patients with lung-RADS 1 from baseline till end of screening surveillance.

Trial sites (6)

Facility	City	Region	Status
National Cancer Centre, Singapore	Singapore	Singapore	Recruiting
Singapore General Hospital	Singapore	Singapore	Recruiting
National Heart Centre Singapore	Singapore	Singapore	Active Not Recruiting
Tan Tock Seng Hospital, Singapore	Singapore	Singapore	Recruiting
Changi General Hospital, Singapore	Singapore	Singapore	Recruiting
Sengkang General Hospital, Singapore	Singapore	Singapore	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05724264 on ClinicalTrials.gov ↗ ← All trials in Singapore