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

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).

Conditions

• Lung Cancer

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• National Cancer Centre, Singapore

  lead OTHER

• Singapore General Hospital

  collaborator OTHER

• National Heart Centre Singapore

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• Sengkang General Hospital

  collaborator OTHER

• Genome Institute of Singapore

  collaborator OTHER

• National University of Singapore

  collaborator OTHER

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

Principal Investigators

• Darren Wan-Teck Lim, MD · National Cancer Centre, Singapore

• Gillianne Geet-Yi Lai, MD · National Cancer Centre, Singapore

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-21

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Singapore

Study Locations