Clinical trial NCT02171286: The Oncopanel Pilot (TOP) Study
Official title: The Oncopanel Pilot (TOP) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Advanced Non-Small Cell Lung Carcinoma
Advanced Melanoma
Gastrointestinal Stromal Tumors
Patients With Diagnosed Malignancies Being Considered for Clinical Trials
Keywords: KRAS
EGFR
BRAF
NRAS and HRAS
PIK3CA
RAS-RAF-MEK-MAPK
HER2
IDH1 and IDH2
ALK
TP53
c-KIT
STAT1&3
PDGFRA
Metastatic colorectal cancer
Advanced non-small cell lung cancer
Advanced melanoma
Gastrointestingal Struma Tumor
Candidate genes implicated as potential prognostic and predictive biomarkers in patients with solid tumours
Circulating Tumor DNA
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: BC Cancer Foundation
First posted: 2014-06-24
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced colorectal cancer, non-small cell lung cancer and melanoma and candidates for clinical trials.

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.

Eligibility criteria: Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:

* Advanced colorectal cancer and eligible for standard KRAS testing,
* Advanced non-small cell lung cancer and eligible for standard EGFR testing,
* Advanced melanoma and eligible for standard BRAF testing,
* Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
* Being considered for potential eligibility in clinical trial.

Primary outcomes:
measure: Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report
timeFrame: 10 business days
Secondary outcomes:
measure: Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received
timeFrame: 1 year
Other outcomes:
measure: 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
timeFrame: 1 year
measure: Percent of patients enrolled on an approved clinical trial related to Oncopanel results
timeFrame: 1 year
measure: Concordance between Oncopanel results and ctDNA sequencing
timeFrame: 1 year
Locations:
city: Abbotsford
country: Canada
facility: Abbotsford Centre, BC Cancer Agency
state: British Columbia
city: Kelowna
country: Canada
facility: BC Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Centre, BC Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Centre, BC Cancer Agency
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Centre, BC Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Hagen Kennecke, MD
role: PRINCIPAL_INVESTIGATOR
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