The Oncopanel Pilot (TOP) Study

Completed

• Conditions: Colorectal Cancer Metastatic; Advanced Non-Small Cell Lung Carcinoma; Patients With Diagnosed Malignancies Being Considered for Clinical Trials; Advanced Melanoma; Gastrointestinal Stromal Tumors

• Registration Number: NCT02171286
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Study Start: 2014-10
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report	10 business days

Secondary Outcome Measures

Name	Time	Method
Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received	1 year

Trial Locations

Locations (5)

BC Cancer Agency - Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Abbotsford Centre, BC Cancer Agency; 🇨🇦 Abbotsford, British Columbia, Canada

Fraser Valley Centre, BC Cancer Agency; 🇨🇦 Surrey, British Columbia, Canada

Vancouver Centre, BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver Island Centre, BC Cancer Agency; 🇨🇦 Victoria, British Columbia, Canada