The Oncopanel Pilot (TOP) Study

NCT02171286 | Completed

• 1 other identifier: H14-01212
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of days between receipt of archival tumour tissue and generation of the OncoPanel Report

  10 business days

Secondary Outcomes (1)

• Percent of cases in which a Oncopanel report is generated on a tumour specimen that has been received

  1 year

Other Outcomes (3)

• 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

  1 year

• Percent of patients enrolled on an approved clinical trial related to Oncopanel results

  1 year

• Concordance between Oncopanel results and ctDNA sequencing

  1 year

Study Arms (1)

No Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced colorectal cancer, non-small cell lung cancer and melanoma and candidates for clinical trials.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator

Study Sites (5)

Abbotsford Centre, BC Cancer Agency

Abbotsford, British Columbia, V2S 0C2, Canada

Location

BC Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

Location

Fraser Valley Centre, BC Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

Vancouver Centre, BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Vancouver Island Centre, BC Cancer Agency

Victoria, British Columbia, V8R 6V5, Canada

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and tissues

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Hereditary Sensory and Autonomic Neuropathies; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Intestinal Neoplasms; Neoplasms by Site; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hagen Kennecke, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 24, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

CA (5)