Molecular Profiling Project

January 31, 2024 updated by: National Cancer Centre, Singapore

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

Recruiting

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: After patient meets the eligibility criteria and consent has been taken
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
Time Frame: After molecular profiling has been completed, every few months up to 2 years
After molecular profiling has been completed, every few months up to 2 years
Collection of subsequent patient treatment status
Time Frame: After molecular profiling has been completed, every few months up to 2 years
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
Time Frame: After molecular profiling has been completed, every few months up to 2 years
After molecular profiling has been completed, every few months up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

December 25, 2025

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 (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATORG001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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