Molecular Profiling Project

Lung Cancer Clinical Trial

Official title:

ATORG001 - Molecular Profiling Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025515
• Other study ID #: ATORG001
• Status: Recruiting
• Start date: January 11, 2019
• Est. completion date: December 25, 2025

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Justine Chu
• Phone: +65 6436 8000
• Email: Justine.chu.j.h[@]nccs.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 25, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Singapore General Hospital

Countries where clinical trial is conducted

Brunei Darussalam,  Hong Kong,  India,  Malaysia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Collection of patient survival status		After molecular profiling has been completed, every few months up to 2 years
Secondary	Collection of subsequent patient treatment status		After molecular profiling has been completed, every few months up to 2 years
Secondary	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

External Links

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