TriOx Malaysia Pilot Study Portal

Welcome

Welcome to the TriOx Malaysia Pilot Study Portal.

This portal supports secure electronic data collection for the study: "Feasibility and Acceptability of a Novel Blood-Based ctDNA Test for Multi-Cancer Early Detection in the Malaysian Population: A Pilot Study."

Authorised study personnel can use this portal to complete sample referral forms, baseline and follow-up case record forms, and study questionnaires. Submitted data are stored securely and PDF copies are generated for study records.

Medical personnel: start study forms Participant Satisfaction Survey

Study Overview

Full Study Title

Feasibility and Acceptability of a Novel Blood-Based ctDNA Test for Multi-Cancer Early Detection in the Malaysian Population: A Pilot Study

Protocol Details

Protocol ID: RSCH ID-25-07267-GEL
Protocol version: Version 1.1
Protocol date: 31/03/2026
Study duration: 1 April 2026 - 30 March 2028
Participant follow-up duration: 12 months

Study Description and Objectives

This pilot study evaluates the feasibility, acceptability, and performance of TriOx, a novel blood-based circulating tumour DNA test for multi-cancer early detection in the Malaysian population.

The study will recruit Malaysian adults from Beacon Hospital, including individuals where cancer is clinically likely and individuals where cancer is unlikely. Participants will provide a blood sample for TriOx testing and will be followed up for 12 months to assess subsequent cancer diagnosis, disease progression, treatment, and participant experience.

General Objective

To establish the acceptability and performance of a novel blood-based ctDNA test for multi-cancer detection within the Malaysian population.

Specific Objectives

To assess the acceptability of the TriOx multi-cancer ctDNA test among Malaysian participants using a participant satisfaction survey administered at baseline and after result disclosure.
To benchmark the diagnostic accuracy of the test in Malaysia by confirming its sensitivity, specificity, and overall ability to distinguish cancer-positive and cancer-negative cases.

Study Design and Population

Design: Pragmatic case-control pilot study
Total sample size: 62 participants
Case group: 28 participants where cancer is likely
Control group: 34 participants where cancer is unlikely

Malaysian adults aged 18 years or above attending Beacon Hospital who meet the study eligibility criteria and are willing to complete a 12-month follow-up phone call.

Asymptomatic individuals with no personal or family history of cancer.
Asymptomatic individuals at high risk of cancer.
Individuals with previous cancer history in remission.
Symptomatic individuals with clinical suspicion of cancer.
Individuals with relevant chronic inflammatory or viral conditions.
Carriers of recognised genetic cancer predisposition conditions.
Individuals with recognised pre-malignant conditions.

Key Study Procedures and Endpoints

At Baseline

Provide written informed consent.
Complete demographic, medical history, lifestyle, and clinical data collection.
Provide two 10 mL whole blood samples in PAXgene circulating cell-free DNA tubes.
Complete an electronic satisfaction survey.

TriOx testing will be performed by the Oxford Molecular Diagnostics Centre.

Results will be reported as ctDNA signal detected or ctDNA signal not detected.

Participants will be followed up by telephone between 11 and 13 months after the baseline visit.

Study Endpoints

Participant satisfaction scores measured at baseline and follow-up.
TriOx test performance, including sensitivity and specificity for detecting any cancer.
Changes in participant cancer status or disease progression within 12 months after baseline testing.

Institutions and Study Team

Principal Investigator

Dato' Dr Mohamed Ibrahim A Wahid
Beacon Hospital

Co-Investigators

Dr Rebecca Tay Sook Hui, Global Precision Diagnostics Sdn. Bhd.

Dato SLJ Dr N. Ravindranathan, Global Doctors Hospital

Law Ruo Xie, Global Precision Diagnostics Sdn. Bhd.

Sponsor

SerenOx Limited
Hampden House, Monument Business Park, Warpsgrove Lane, Chalgrove, Oxford, Oxfordshire, United Kingdom, OX44 7RW

Study Site

Global Precision Diagnostics Sdn. Bhd.
Lower Ground, 1, Beacon Hospital, Off Jalan 215, Seksyen 51, 46050 Petaling Jaya, Selangor, Malaysia

Testing Laboratory

Oxford Molecular Diagnostics Centre, United Kingdom