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| Name | Class |
|---|---|
| BC Cancer Foundation | OTHER |
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The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.
The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.
Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.
Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report | 10 business days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of cases in which a genotypic finding identified by the Oncopanel is repeated on standard clinical assay for the purpose of guiding subsequent therapy | 1 year | |
| Percent of patients enrolled on an approved clinical trial related to Oncopanel results | 1 year |
Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:
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Patients with advanced colorectal cancer, non-small cell lung cancer and melanoma and candidates for clinical trials.
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| Name | Affiliation | Role |
|---|---|---|
| Hagen Kennecke, MD | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbotsford Centre, BC Cancer Agency | Abbotsford British Columbia | British Columbia | V2S 0C2 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24768039 | Background | Dienstmann R, Dong F, Borger D, Dias-Santagata D, Ellisen LW, Le LP, Iafrate AJ. Standardized decision support in next generation sequencing reports of somatic cancer variants. Mol Oncol. 2014 Jul;8(5):859-73. doi: 10.1016/j.molonc.2014.03.021. Epub 2014 Apr 4. | |
| 24797823 | Background | Johnson DB, Dahlman KH, Knol J, Gilbert J, Puzanov I, Means-Powell J, Balko JM, Lovly CM, Murphy BA, Goff LW, Abramson VG, Crispens MA, Mayer IA, Berlin JD, Horn L, Keedy VL, Reddy NM, Arteaga CL, Sosman JA, Pao W. Enabling a genetically informed approach to cancer medicine: a retrospective evaluation of the impact of comprehensive tumor profiling using a targeted next-generation sequencing panel. Oncologist. 2014 Jun;19(6):616-22. doi: 10.1634/theoncologist.2014-0011. Epub 2014 May 5. |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Whole blood, plasma and tissues
| Concordance between Oncopanel results and ctDNA sequencing | 1 year |
| BC Cancer Agency - Centre for the Southern Interior |
| Kelowna |
| British Columbia |
| V1Y5L3 |
| Canada |
| Fraser Valley Centre, BC Cancer Agency | Surrey | British Columbia | V3V 1Z2 | Canada |
| Vancouver Centre, BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Vancouver Island Centre, BC Cancer Agency | Victoria | British Columbia | V8R 6V5 | Canada |
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| 18632602 | Background | Marks JL, Gong Y, Chitale D, Golas B, McLellan MD, Kasai Y, Ding L, Mardis ER, Wilson RK, Solit D, Levine R, Michel K, Thomas RK, Rusch VW, Ladanyi M, Pao W. Novel MEK1 mutation identified by mutational analysis of epidermal growth factor receptor signaling pathway genes in lung adenocarcinoma. Cancer Res. 2008 Jul 15;68(14):5524-8. doi: 10.1158/0008-5472.CAN-08-0099. |
| 24323026 | Background | Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9. |
| 22180306 | Background | Borger DR, Tanabe KK, Fan KC, Lopez HU, Fantin VR, Straley KS, Schenkein DP, Hezel AF, Ancukiewicz M, Liebman HM, Kwak EL, Clark JW, Ryan DP, Deshpande V, Dias-Santagata D, Ellisen LW, Zhu AX, Iafrate AJ. Frequent mutation of isocitrate dehydrogenase (IDH)1 and IDH2 in cholangiocarcinoma identified through broad-based tumor genotyping. Oncologist. 2012;17(1):72-9. doi: 10.1634/theoncologist.2011-0386. Epub 2011 Dec 16. |
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| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D007414 | Intestinal Neoplasms |
| D009371 | Neoplasms by Site |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |