Lung CancerNCT05724264
SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE)
A study testing Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays in people with Lung Cancer, run by National Cancer Centre, Singapore at 6 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesSingapore
- Study dates
- 21 Jul 2022to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- Uncontrolled medical comorbidity on enrolment
- Previous diagnosis of cancer
- Bleeding diathesis that will preclude blood sampling
- Fear of blood draw or needles
- Pregnancy
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Singapore6 sites, 5 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore, 168583
- Recruiting
Singapore General Hospital
Singapore, 169608
- Active, not recruiting
National Heart Centre Singapore
Singapore, 169609
- Recruiting
Tan Tock Seng Hospital, Singapore
Singapore, 308433
- Recruiting
Changi General Hospital, Singapore
Singapore, 529889
- Recruiting
Sengkang General Hospital, Singapore
Singapore, 544886
About this study
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:
Read more
- 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).
Read the detailed description
This is a single arm cohort screening study. Briefly, this prospective study will involve screening the general population with risk factors for lung cancers with the aim of investigating the feasibility of implementing LDCT screening in the local context. Both smokers and non-smokers with the known risk factor of family history of lung cancer up to 2nd degree are eligible to participate in the study. Depending on emerging epidemiological data, additional high-risk cohorts may be included in this study. Subject demographics, smoking history, exposure to the aforementioned environmental factors, family history of lung cancer, history of tuberculosis and comorbidity will be captured in detail. The age range for inclusion is 55 to 74 years. Given the higher proportion of never-smoker lung cancer in Singapore, we aim to recruit 650 non-smoking and 350 smoking individuals for our study.
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.
Participants with LDCT scan results of Lung-RADS score 2 and above will be referred to the nodule clinic under SingHealth DUKE-NUS Lung Centre for standardized follow-ups and/or diagnostic evaluation. These patients will undergo clinical surveillance (up to maximum of 5 years depending on their nodules) and will be managed as per current clinical practice. Participants with LDCT scan results of Lung-RADS score of 1 will undergo further screening surveillance which will end after 2 years if they have no nodules detected.
- Conditions
- Lung Cancer
- Being tested
- Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays
- Keywords
- Low Dose CT (LDCT) Screening, Lung CT Screening Reporting & Data System (Lung-RADS), Lung cancer screening in smokers and non-smokers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT of the Chest (LDCT) + Sampling for Biomarker AssaysDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Low-dose CT of the Chest (LDCT) + Blood sampling | Experimental | Not described Receives: Diagnostic Test: Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting Low Dose CT (LDCT) screening in at-risk populations (1).
Diagnostic accuracy of LDCT at baseline.
Measured: At Baseline.
Feasibility of conducting LDCT screening in at-risk populations (2).
Compliance with LDCT screens for patients with lung-RADS 1 from baseline till end of screening surveillance.
Measured: Up to 2 years after Baseline.
Secondary outcomes (5)
The utility of blood-based biomarker assays in improving the performance of LDCT to detect lung cancer and discriminate risk of malignancy. (1)
Diagnostic accuracy and discrimination ability of biomarker assay in the detection of lung cancer will be assessed via sensitivity, specificity, PPV, NPV and area under curve (AUC) of the receiver operating characteristic curve.
Measured: Up to 7 years after Baseline.
The utility of blood-based biomarker assays in improving the performance of LDCT to detect lung cancer and discriminate risk of malignancy. (2)
Changes in biomarker levels over time in relation to lung cancer diagnosis. Time series plot of biomarker levels by whether participants have lung cancer diagnosed will be created. Linear mixed effect models will be used to assess the changes in biomarker levels over time in the group of participants with lung cancer diagnosed, and to compare whether the changes observed are different from those experienced by the group of patients with no lung cancer diagnosed.
Measured: Up to 7 years after Baseline.
Comparison of the diagnostic performance of each combination of a biomarker assay and LDCT screening against that of LDCT screening.
A biomarker assay that can accurately diagnose lung cancer will then be combined with LDCT screening via a re-definition of what constitute a positive screening test (e.g. Lung-RADS 3 to 4X or biomarker assay above a certain threshold). The additional diagnostic value of a biomarker assay will be assessed by comparing the diagnostic performance of the combination of the biomarker assay and LDCT screening against that based on LDCT screening alone.
Measured: Up to 7 years after Baseline.
The lung cancer detection rate at each round of screening.
Screen detected lung cancer rate at baseline, and interval cancers detected between screening rounds.
Measured: Up to 2 years after Baseline.
The morbidity of LDCT screening.
Adverse events relating to LDCT screening.
Measured: Up to 2 years after Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start21 Jul 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, National Heart Centre Singapore, Changi General Hospital, Sengkang General Hospital, Genome Institute of Singapore, National University of Singapore, Duke-NUS Graduate Medical School, Tan Tock Seng Hospital
- Responsible party
- Sponsor
- Investigators
- Darren Wan-Teck Lim, MD, Principal investigator, National Cancer Centre, SingaporeGillianne Geet-Yi Lai, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724264
- Sponsor's protocol ID
- 2020/2962
- Status last verified
- May 2026
- First submitted
- 19 Jan 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified and/or anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE)
- ClinicalTrials.gov ID
- NCT05724264
- Acronym / sponsor ID
- 2020/2962
- Conditions
- Lung Cancer
- Keywords
- Low Dose CT (LDCT) Screening, Lung CT Screening Reporting & Data System (Lung-RADS), Lung cancer screening in smokers and non-smokers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, National Heart Centre Singapore, Changi General Hospital, Sengkang General Hospital, Genome Institute of Singapore, National University of Singapore, Duke-NUS Graduate Medical School, Tan Tock Seng Hospital
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a single arm cohort screening study. Briefly, this prospective study will involve screening the general population with risk factors for lung cancers with the aim of investigating the feasibility of implementing LDCT screening in the local context. Both smokers and non-smokers with the known risk factor of family history of lung cancer up to 2nd degree are eligible to participate in the study. Depending on emerging epidemiological data, additional high-risk cohorts may be included in this study. Subject demographics, smoking history, exposure to the aforementioned environmental factors, family history of lung cancer, history of tuberculosis and comorbidity will be captured in detail. The age range for inclusion is 55 to 74 years. Given the higher proportion of never-smoker lung cancer in Singapore, we aim to recruit 650 non-smoking and 350 smoking individuals for our study.
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.
Participants with LDCT scan results of Lung-RADS score 2 and above will be referred to the nodule clinic under SingHealth DUKE-NUS Lung Centre for standardized follow-ups and/or diagnostic evaluation. These patients will undergo clinical surveillance (up to maximum of 5 years depending on their nodules) and will be managed as per current clinical practice. Participants with LDCT scan results of Lung-RADS score of 1 will undergo further screening surveillance which will end after 2 years if they have no nodules detected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose CT of the Chest (LDCT) + Blood sampling | Experimental | Diagnostic Test: Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- Uncontrolled medical comorbidity on enrolment
- Previous diagnosis of cancer
- Bleeding diathesis that will preclude blood sampling
- Fear of blood draw or needles
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose CT of the Chest (LDCT) + Sampling for Biomarker AssaysLDCT 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. | Diagnostic test | Low-dose CT of the Chest (LDCT) + Blood sampling |
Primary outcome
Feasibility of conducting Low Dose CT (LDCT) screening in at-risk populations (1).
Time frame: At Baseline.
Diagnostic accuracy of LDCT at baseline.
Feasibility of conducting LDCT screening in at-risk populations (2).
Time frame: Up to 2 years after Baseline.
Compliance with LDCT screens for patients with lung-RADS 1 from baseline till end of screening surveillance.
5 secondary outcomes
The utility of blood-based biomarker assays in improving the performance of LDCT to detect lung cancer and discriminate risk of malignancy. (1)
Time frame: Up to 7 years after Baseline.
The utility of blood-based biomarker assays in improving the performance of LDCT to detect lung cancer and discriminate risk of malignancy. (2)
Time frame: Up to 7 years after Baseline.
Comparison of the diagnostic performance of each combination of a biomarker assay and LDCT screening against that of LDCT screening.
Time frame: Up to 7 years after Baseline.
The lung cancer detection rate at each round of screening.
Time frame: Up to 2 years after Baseline.
The morbidity of LDCT screening.
Time frame: Up to 2 years after Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. De-identified and/or anonymized data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darren Wan-Teck Lim, MD principal investigator
National Cancer Centre, Singapore
Gillianne Geet-Yi Lai, MD principal investigator
National Cancer Centre, Singapore
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays in people with Lung Cancer, run by National Cancer Centre, Singapore at 6 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darren Wan-Teck Lim, MD (64368000, darren.lim.w.t@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of conducting Low Dose CT (LDCT) screening in at-risk populations (1). (time frame: At Baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.