Genome Sequencing for Personalized Cancer Therapy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: British Columbia Cancer Agency
Disqualifiers: Significant medical condition, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The genomic heterogeneity of cancers implies that to effectively use targeted therapies the investigators will need to assess each individual cancer and match it to a biologically relevant targeted therapy. The investigators will use full genome sequencing to try to identify cancer "drivers" and corresponding drugs that may inhibit these pathways.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Genome Sequencing for Personalized Cancer Therapy?
Research shows that next-generation sequencing (NGS) can identify specific genetic changes in cancer, which helps doctors choose treatments that are more likely to work for individual patients. However, the effectiveness can vary, as some patients benefit from treatments based on NGS results, while others do not.
12345Is genome sequencing safe for humans?
The research articles do not provide specific safety data for genome sequencing, but they discuss its widespread use in cancer research and treatment, suggesting it is generally considered safe for these applications.
23467How is genome sequencing used in personalized cancer therapy different from other treatments?
Genome sequencing (also known as next-generation sequencing or NGS) is unique because it analyzes the entire genetic makeup of a cancer, identifying specific mutations that can guide personalized treatment plans. This approach allows for tailored therapies based on the genetic profile of the tumor, potentially improving treatment effectiveness compared to standard treatments that do not consider individual genetic differences.
34689Eligibility Criteria
This trial is for adults with cancer who can provide tissue samples, have a life expectancy of at least 6 months, and are fit enough to potentially participate in future clinical trials. They must be willing to share their genomic data and understand it may guide treatment options.Inclusion Criteria
I am open to being contacted for future studies and believe I would be fit for clinical trials.
My organs are working well.
I agree to let my stored tissue samples be used for research, even if they are all used up.
+8 more
Exclusion Criteria
I do not want to know about specific genetic findings from my tests.
Significant medical condition that in the opinion of the treating or consenting oncologist and/or the POG central office review team renders the subject not suitable for participation. This includes the likelihood that a subject would be suitable for a clinical trial within 12 weeks after POG biopsy
Unwilling or unable to provide treatment and outcome follow-up information to the BC Cancer or affiliated investigators
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Genome Sequencing
Comprehensive DNA and RNA sequencing is performed followed by an in-depth bioinformatic analysis to identify somatic mutations, gene expression changes or other abnormalities
Ongoing
Weekly meetings for genomic report discussions
Treatment Decision
Clinicians discuss genomic reports and come to a consensus on appropriate systemic therapies based on results
Ongoing
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The trial uses full genome sequencing on individual cancers to identify 'drivers' of the disease and match them with targeted therapies that could inhibit these pathways. It aims to personalize cancer treatment based on genetic analysis.
1Treatment groups
Experimental Treatment
Group I: Genome SequencingExperimental Treatment1 Intervention
There is only one arm to this study.
Genome sequencing is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
🇺🇸 Approved in United States as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
- Genetic testing
🇨🇦 Approved in Canada as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
🇯🇵 Approved in Japan as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
🇨🇳 Approved in China as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
🇨🇭 Approved in Switzerland as Genomic sequencing for:
- Diagnostic tool for various cancers
- Personalized medicine
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Cancer AgencyVancouver, Canada
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Who Is Running the Clinical Trial?
British Columbia Cancer AgencyLead Sponsor
BC Cancer FoundationCollaborator
References
Next-generation sequencing in patients with advanced cancer: are we ready for widespread clinical use? A single institute's experience. [2018]The next-generation sequencing (NGS) assay targeting cancer-relevant genes has been adopted widely for use in patients with advanced cancer. The primary aim of this study was to assess the clinical utility of commercially available NGS. We retrospectively collected demographic and clinicopathologic data, recommended therapy, and clinical outcomes of 30 patients with a variety of advanced solid tumors referred to Foundation Medicine NGS. The initial pathologic examination was performed at the pathology department of the referring hospital. The comprehensive clinical NSG assay was performed on paraffin-embedded tumor samples using the Clinical Laboratory Improvement Amendments-certified FoundationOne platform. The median number of genomic alterations was 3 (0-19). The median number of therapies with potential benefit was 2 (0-8). In 12 cases, a comprehensive clinical NGS assay did not indicate any therapy with potential benefit according to the genomic profile. Ten of the 30 patients received treatments recommended by genomic profile results. In six of the 10 cases, disease progressed within 2 months and four patients died within 3 months of treatment initiation. Three of the 30 patients benefited from a comprehensive clinical NGS assay and the subsequent recommended therapy. The median PFS was 12 weeks (95% confidence interval 10-57) in patients treated with molecularly targeted agents chosen on the basis of tumor genomic profiling versus 48 weeks (95% confidence interval 8-38) in the control group treated with physician choice therapy (P=0.12). Our study suggests that NGS can detect additional treatment targets in individual patients, but prospective medical research and appropriate clinical guidelines for proper clinical use are vital.
Improving Time to Molecular Testing Results in Patients With Newly Diagnosed, Metastatic Non-Small-Cell Lung Cancer. [2023]Next-generation sequencing (NGS) is a crucial component of evaluation of patients with newly diagnosed metastatic non-small-cell lung cancer (NSCLC) to determine appropriate first-line treatment. This quality improvement project aimed to reduce time to NGS results in patients with metastatic NSCLC.
Plasma cfDNA Genotyping in Hospitalized Patients With Suspected Metastatic NSCLC. [2022]Next-generation sequencing (NGS) is an important component of first-line treatment selection for metastatic non-small-cell lung cancer (NSCLC) and is typically ordered by medical oncologists in the outpatient setting after the pathologic diagnosis has been established. Time to treatment initiation is an important clinical challenge, especially for patients with rapidly progressive disease.
Cancer gene profiling in non-small cell lung cancers reveals activating mutations in JAK2 and JAK3 with therapeutic implications. [2022]Next-generation sequencing (NGS) of cancer gene panels are widely applied to enable personalized cancer therapy and to identify novel oncogenic mutations.
Next-Generation Sequencing in 305 Consecutive Patients: Clinical Outcomes and Management Changes. [2020]Next-generation sequencing (NGS) is increasingly used to identify actionable mutations for oncology treatment. We examined the results and use of NGS assays at our institution.
Complexity of genome sequencing and reporting: Next generation sequencing (NGS) technologies and implementation of precision medicine in real life. [2019]The finalization of the Human Genome Project in 2003 paved the way for a deeper understanding of cancer, favouring a faster progression towards "personalized" medicine. Research in oncology has progressively focused on the sequencing of cancer genomes, to better understand the genetic basis of tumorigenesis and identify actionable alterations to guide cancer therapy. Thanks to the development of next-generation-sequencing (NGS) techniques, sequencing of tumoral DNA is today technically easier, faster and cheaper. Commercially available NGS panels enable the detection of single or global genomic alterations, namely gene mutation and mutagenic burden, both on germline and somatic DNA, potentially predicting the response or resistance to cancer treatments. Profiling of tumor DNA is nowadays a standard in cancer research and treatment. In this review we discuss the history, techniques and applications of NGS in cancer care, under a "personalized tailored therapy" perspective.
The clinical utility of molecular genetic cancer profiling. [2018]Next-Generation-Sequencing (NGS) has enabled gene mutation profiling - cataloguing sequence variants and modifications in clinical assays encompassing tens to thousands of genes in tumors and in germlines. The clinical benefit of applying multi-gene NGS to diverse applications in various malignancies remains to be demonstrated.
The Impact of Next Generation Sequencing in Cancer Research. [2020]Next generation sequencing (NGS) describes the technical revolution that enabled massively parallel sequencing of fragmented nucleic acids, thus making possible our current genomic understanding of cancers [...].
Optimization of a microfluidics-based next generation sequencing assay for clinical oncology diagnostics. [2022]Massively parallel, or next-generation, sequencing is a powerful technique for the assessment of somatic genomic alterations in cancer samples. Numerous gene targets can be interrogated simultaneously with a high degree of sensitivity. The clinical standard of care for many advanced solid and hematologic malignancies currently requires mutation analysis of several genes in the front-line setting, making focused next generation sequencing (NGS) assays an effective tool for clinical molecular diagnostic laboratories.