SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE)
Recruiting · NCT05724264 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
6 locations listed.
- National Cancer Centre, Singapore - Singapore, Singapore
- Singapore General Hospital - Singapore, Singapore
- National Heart Centre Singapore - Singapore, Singapore
- Tan Tock Seng Hospital, Singapore - Singapore, Singapore
- Changi General Hospital, Singapore - Singapore, Singapore
- Sengkang General Hospital, Singapore - Singapore, Singapore