The Oncopanel Pilot (TOP) Study
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|ClinicalTrials.gov Identifier: NCT02171286|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : April 14, 2017
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.
|Condition or disease|
|Colorectal Cancer Metastatic Advanced Non-Small Cell Lung Carcinoma Advanced Melanoma Gastrointestinal Stromal Tumors 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.
|Study Type :||Observational|
|Actual Enrollment :||432 participants|
|Official Title:||The Oncopanel Pilot (TOP) Study|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
- Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report [ Time Frame: 10 business days ]
- Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received [ Time Frame: 1 year ]
- 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 [ Time Frame: 1 year ]
- Percent of patients enrolled on an approved clinical trial related to Oncopanel results [ Time Frame: 1 year ]
- Concordance between Oncopanel results and ctDNA sequencing [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171286
|Canada, British Columbia|
|Abbotsford Centre, BC Cancer Agency|
|Abbotsford, British Columbia, Canada, V2S 0C2|
|BC Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y5L3|
|Fraser Valley Centre, BC Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|Vancouver Centre, BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Vancouver Island Centre, BC Cancer Agency|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Hagen Kennecke, MD||British Columbia Cancer Agency|