Targeted Nucleic Acid Evaluation for Cancer

(OCTANE Trial)

Recruiting at 6 trial locations

Overseen By Samanta Del Rossi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: More than 2 lines cytotoxic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which cancer treatments work best for different patients by examining specific characteristics, or biomarkers, of their cancer. Participants will provide previously collected tumor samples to identify the most suitable treatment options and contribute to a research registry. This study suits individuals with advanced solid tumors who are about to begin systemic therapy and have sufficient stored tumor tissue for biomarker testing. By linking patient health data and DNA sequences, the trial seeks to gain new insights into cancer and its treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage treatment evaluation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biomarker testing is safe?

Research has shown that biomarker testing is safe and easy for patients. Studies have found that this testing examines genes and proteins to gain insights into a specific cancer, aiding doctors in selecting the best treatment for each patient. The process involves no medication or invasive procedures, resulting in no direct side effects or negative reactions from the testing itself.

Biomarker testing has been successfully used in many areas of cancer treatment, demonstrating its safety. Its primary goal is to provide crucial information that guides treatment choices. Since this testing focuses on information collection rather than altering bodily functions, it carries very low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this biomarker testing approach because it represents a shift towards personalized medicine in cancer treatment. Unlike traditional therapies that treat cancer based on its location in the body, biomarker testing identifies specific genetic mutations or expressions in a tumor. This allows for more targeted treatments that can be more effective and less toxic. By honing in on the unique characteristics of each patient's cancer, this method has the potential to improve outcomes and reduce side effects compared to the one-size-fits-all approach of conventional chemotherapy or radiation.

What evidence suggests that biomarker testing is effective for cancer?

Research shows that biomarker testing to guide cancer treatment can lead to better patient outcomes. Biomarkers are specific features of the cancer that indicate how the disease might behave or respond to treatments. Studies have found that treatment based on these biomarkers often leads to better results. This method helps doctors select the most effective treatments by focusing on the unique traits of each patient's cancer. Overall, biomarker testing is a promising tool for personalizing cancer care and improving treatment success. ^{5 6 7 8 9}

Who Is on the Research Team?

Philippe Bedard, MD

Principal Investigator

Princess Margaret Hospital, Canada

Lillian Siu, MD

Principal Investigator

Princess Margaret Hospital, Canada

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy.

All patients must have sufficient FFPE archived tumor tissue for molecular profiling.

Patient's ECOG performance status equal to 0 or 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of archival tumor samples and blood samples for biomarker data and future research

1-2 weeks

1 visit (in-person)

Data Analysis and Reporting

Targeted DNA sequencing results are reported to the treating oncologist and stored in a clinical research database

4-6 weeks

Follow-up

Participants are monitored for additional data collection and health record review

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Biomarker Testing

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571259/

Cancer Biomarkers and Precision Oncology: A Review of ... In the realm of precision medicine, patients with cancer who receive treatment based on biomarker-guided approaches have shown improved outcomes ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836387

Biomarker Testing, Treatment Selection, and Cost of Care ... For example, the percentage of patients with NSCLC who received CGP testing increased from 12% in 2018 to 33% in 2021 to 2022 (percentages were ...

3. nature.com nature.com/articles/s41392-024-01823-2

Tumor biomarkers for diagnosis, prognosis and targeted ... Tumor biomarkers exist in tumor tissues or body fluids such as blood, urine, stool, saliva, and are produced by the tumor or the body's response to the tumor.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010854523004459/pdf

Recent advances of nucleic acid-based cancer biomarkers ... This comprehensive review embarks on a systematic exploration, delving into the classifications, properties, and functions of NABCBs.

5. cell.com cell.com/cell/fulltext/S0092-8674(24)00244-7

Cancer biomarkers: Emerging trends and clinical ... In this review, we discuss the scientific milestones of cancer biomarkers and explore future possibilities to improve the management of patients with solid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12520037/

Factors Associated With Implementation of Biomarker Testing ... We aimed to synthesize evidence on factors associated with implementation of biomarker testing and strategies to improve its clinical uptake ...

7. fightcancer.org fightcancer.org/what-we-do/access-biomarker-testing

Access to Biomarker Testing Biomarker testing helps ensure cancer patients get the right treatment at the right time. It allows doctors to precisely target a specific cancer so patients ...

8. cancer.gov cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment

Biomarker Testing for Cancer Treatment - NCI Biomarker testing is a way to look for genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer.

9. astrazeneca-us.com astrazeneca-us.com/media/articles/2023/precision-medicine-in-oncology-accelerating-biomarker-testing-to-help-advance-patient-outcomes-09282023.html

Precision Medicine in Oncology: Accelerating Biomarker ... In this article, we will delve into the importance of biomarker testing, highlight the potential of circulating tumor DNA (ctDNA), discuss ...