NCT05724264

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
45mo left

Started Jul 2022

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2022Dec 2029

Study Start

First participant enrolled

July 21, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

7.5 years

First QC Date

January 19, 2023

Last Update Submit

January 6, 2025

Conditions

Lung Cancer

Keywords

Low Dose CT (LDCT) ScreeningLung CT Screening Reporting & Data System (Lung-RADS)Lung cancer screening in smokers and non-smokers

Outcome Measures

Primary Outcomes (2)

  • Feasibility of conducting Low Dose CT (LDCT) screening in at-risk populations (1).

    Diagnostic accuracy of LDCT at baseline.

    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.

    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)

    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)

    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.

    Up to 7 years after Baseline.

  • The lung cancer detection rate at each round of screening.

    Up to 2 years after Baseline.

  • The morbidity of LDCT screening.

    Up to 2 years after Baseline.

Other Outcomes (4)

  • To evaluate if computer-aided diagnosis strategies can enhance LDCT screening.

    Up to 2 years after Baseline.

  • To determine the feasibility of screening for concomitant coronary artery disease.

    Up to 2 years after Baseline.

  • To study gene-environment-lifestyle interactions in the screened population.

    Up to 7 years after Baseline.

  • +1 more other outcomes

Study Arms (1)

Low-dose CT of the Chest (LDCT) + Blood sampling

EXPERIMENTAL
Diagnostic Test: Low-dose CT of the Chest (LDCT) + Sampling for Biomarker Assays

Interventions

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.

Low-dose CT of the Chest (LDCT) + Blood sampling

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • Uncontrolled medical comorbidity on enrolment
  • Previous diagnosis of cancer
  • Bleeding diathesis that will preclude blood sampling
  • Fear of blood draw or needles
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cancer Centre, Singapore

Singapore, 168583, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Darren Wan-Teck Lim, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

  • Gillianne Geet-Yi Lai, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren Wan-Teck Lim, MD

CONTACT

64368000darren.lim.w.t@singhealth.com.sg

Gillianne Geet-Yi Lai, MD

CONTACT

64368000gillianne.lai.g.y@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 13, 2023

Study Start

July 21, 2022

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified and/or anonymized data.

Locations

SG(3)