Molecular Profiling Project

ATORG001 - Molecular Profiling Project

In this study, the investigators plan to undertake comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype in the local population.

Study Overview

• Status: Suspended
• Conditions: Non-Small Cell Lung Cancer; Lung Cancer

Detailed Description

ATORG is undertaking a comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype. These mutations are screened using the Oncomine Focus Assay, where 52 genetic alterations - including hotspots, single nucleotide variants, indels, CNVs, and gene fusions - may be detected in a single workflow. Oncomine™ Comprehensive Assay v3, an NGS assay which tests for 161 unique genes (Appendix IV), will be used in a later stage of the study, allowing for broader coverage of potentially targetable alterations. Both assays have a rapid turnaround time and addresses one of the main challenges of solid tumor testing - the scarcity of tissue material - requiring minimal sample input and thus enabling the use of a wider range of sample quality and types, including small biopsies and fine needle aspirates. However, as the list of therapeutically relevant biomarkers continues to expand over time, broader NGS panels will be used subsequently to incorporate emerging alterations. In addition, relevant baseline clinical characteristics are collated e.g. patient demographics, smoking history, number of lines of therapy, as well as outcomes including access to targeted therapies, immune checkpoint inhibitors and overall survival. Through comprehensive annotation of clinical-pathological-molecular characteristics, this study will provide a means to rationalize the application of diagnostic tests, as well as identify prognostic and predictive factors in the treatment of Asian lung cancers.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Brunei
  • Brunei, Brunei
    • The Brunei Cancer Centre
• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Integrated Oncology Centre
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong, Department of Clinical Oncology
• India
  • New Delhi, India
    • Rajiv Ghandhi Cancer Institute and Research Centre
• Malaysia
  • George Town, Malaysia
    • Penang Adventist Hospital
  • Kuala Lumpur, Malaysia
    • Pantai Hospital, Kuala Lumpur
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre, Clinical Oncology Department
  • Petaling Jaya, Malaysia
    • Beacon Hospital
• Singapore
  • Singapore, Singapore
    • National Cancer Centre Singapore
• Thailand
  • Bangkok, Thailand
    • Phramongkutklao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Asian patients with Non-Small Cell Lung Cancer (NSCLC)

Description

Inclusion Criteria:

• The availability of sufficient archival tumor tissue specimen (15 slides of 4 microns per section)
• Age ≥ 21 years
• WHO performance status ≤ 2
• Life expectancy of ≥ 12 weeks

• Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):

  • Adequate bone marrow function as shown by: ANC ≥ 1.0 x 10^9/L, Platelets ≥ 75 x 10^9/L, Hb ≥ 7.5 g/dL
  • Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤3.0 x ULN if liver metastases are present)
• Willing to provide signed informed consent
• Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment

Exclusion Criteria:

- No more than 3 lines of cytotoxic chemotherapy at the time of enrolment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular profiling of lung cancer specimens	Lung cancer specimens will be collected and profiled at a molecular level to evaluate the molecular epidemiology of NSCLC in Asia	After patient meets the eligibility criteria and consent has been taken

Secondary Outcome Measures

Outcome Measure	Time Frame
Collection of patient survival status	After molecular profiling has been completed, every few months up to 2 years
Collection of subsequent patient treatment status	After molecular profiling has been completed, every few months up to 2 years
Collection of the clinical outcomes of the subsequent treatments the patients receive	After molecular profiling has been completed, every few months up to 2 years

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Daniel Tan, BSc, MBBS, MRCP, National Cancer Centre, Singapore

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: June 15, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Molecular profiling; Targeted therapies; Next-Generation Sequencing (NGS); Oncomine Focus Panel Assay; Driver oncogene; PD-L1 Immunohistochemistry (IHC, Dako 22C3); Hotspots; Single Nucleotide Variants (SNVs); Insertions/ Deletions (Indels); Copy Number Variation (CNVs),; Gene Fusions; Formalin-Fixed; Paraffin Embedded (FFPE) extracted DNA and RNA; Ion PGM™ System; Oncomine™ Comprehensive Assay v3
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ATORG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO