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Trial record 4 of 5 for:    24024839 [PUBMED-IDS]

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
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
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.


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

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.


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Study Type : Observational
Actual Enrollment : 432 participants
Observational Model: Other
Time Perspective: Other
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


Group/Cohort
No Treatment



Primary Outcome Measures :
  1. Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report [ Time Frame: 10 business days ]

Secondary Outcome Measures :
  1. Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received [ Time Frame: 1 year ]

Other Outcome Measures:
  1. 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 ]
  2. Percent of patients enrolled on an approved clinical trial related to Oncopanel results [ Time Frame: 1 year ]
  3. Concordance between Oncopanel results and ctDNA sequencing [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma and tissues


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced colorectal cancer, non-small cell lung cancer and melanoma and candidates for clinical trials.
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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
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Principal Investigator: Hagen Kennecke, MD British Columbia Cancer Agency

Publications:

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02171286     History of Changes
Other Study ID Numbers: H14-01212
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by British Columbia Cancer Agency:
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

Additional relevant MeSH terms:
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Melanoma
Colorectal Neoplasms
Lung Neoplasms
Gastrointestinal Stromal Tumors
Carcinoma, Non-Small-Cell Lung
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms