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Trial Title:
SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE)
NCT ID:
NCT05724264
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: 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
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays
Description:
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.
Arm group label:
Low-dose CT of the Chest (LDCT) + Blood sampling
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).
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Cancer Centre, Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Singapore General Hospital
Address:
City:
Singapore
Zip:
169608
Country:
Singapore
Status:
Recruiting
Facility:
Name:
National Heart Centre Singapore
Address:
City:
Singapore
Zip:
169609
Country:
Singapore
Status:
Recruiting
Start date:
July 21, 2022
Completion date:
December 31, 2029
Lead sponsor:
Agency:
National Cancer Centre, Singapore
Agency class:
Other
Collaborator:
Agency:
Singapore General Hospital
Agency class:
Other
Collaborator:
Agency:
National Heart Centre Singapore
Agency class:
Other
Collaborator:
Agency:
Changi General Hospital
Agency class:
Other
Collaborator:
Agency:
Sengkang General Hospital
Agency class:
Other
Collaborator:
Agency:
Genome Institute of Singapore
Agency class:
Other
Collaborator:
Agency:
National University of Singapore
Agency class:
Other
Collaborator:
Agency:
Duke-NUS Graduate Medical School
Agency class:
Other
Source:
National Cancer Centre, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724264
