Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
432 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-10-31
Study Completion Date
2017-03-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Colorectal Cancer Metastatic
Advanced Non-Small Cell Lung Carcinoma
Advanced Melanoma
Gastrointestinal Stromal Tumors
Patients With Diagnosed Malignancies Being Considered for Clinical Trials
Study Design
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Observational Model Type
OTHER
Study Time Perspective
OTHER
Study Groups
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No Treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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BC Cancer Foundation
OTHER
Sponsor Role
collaborator
British Columbia Cancer Agency
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hagen Kennecke, MD
Role: PRINCIPAL_INVESTIGATOR
British Columbia Cancer Agency
Locations
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Abbotsford Centre, BC Cancer Agency
Abbotsford, British Columbia, Canada
Site Status
BC Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Site Status
Fraser Valley Centre, BC Cancer Agency
Surrey, British Columbia, Canada
Site Status
Vancouver Centre, BC Cancer Agency
Vancouver, British Columbia, Canada
Site Status
Vancouver Island Centre, BC Cancer Agency
Victoria, British Columbia, Canada
Site Status
Countries
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Canada
References
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Other Identifiers
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H14-01212
Identifier Type: -
Identifier Source: org_study_id
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