Molecular Profiling Project

NCT ID: NCT04025515

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-11

Study Completion Date

2025-12-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Tan, BSc, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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The Brunei Cancer Centre

Brunei, , Brunei

Site Status RECRUITING

Hong Kong Integrated Oncology Centre

Hong Kong, , Hong Kong

Site Status RECRUITING

The Chinese University of Hong Kong, Department of Clinical Oncology

Hong Kong, , Hong Kong

Site Status RECRUITING

Rajiv Ghandhi Cancer Institute and Research Centre

New Delhi, , India

Site Status RECRUITING

Penang Adventist Hospital

George Town, , Malaysia

Site Status RECRUITING

Pantai Hospital, Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status RECRUITING

University Malaya Medical Centre, Clinical Oncology Department

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Beacon Hospital

Petaling Jaya, , Malaysia

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Brunei Hong Kong India Malaysia Singapore Thailand

Central Contacts

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Amanda Lau

Role: CONTACT

+65 6306 1748

Related Links

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Other Identifiers

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ATORG001

Identifier Type: -

Identifier Source: org_study_id

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