Lung Cancer, Non-Small Cell Lung Cancer
Conditions
Keywords
Oncomine Focus Panel Assay, Molecular profiling, Targeted therapies, Driver oncogene, Next-Generation Sequencing (NGS), 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
Brief 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.
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.
Interventions
None listed
Sponsors
National Cancer Centre, Singapore
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular profiling of lung cancer specimens | 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 |
Secondary
| 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 |
Countries
Brunei, Hong Kong, India, Malaysia, Singapore, Thailand
Contacts
PRINCIPAL_INVESTIGATORDaniel Tan, BSc, MBBS, MRCP
National Cancer Centre, Singapore
Outcome results
None listed