Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02171286
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2014-06-18
Brief Title:
The Oncopanel Pilot TOP Study
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
The Oncopanel Pilot TOP Study
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 STAT13 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 tumors 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 tumors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None