Genomic Sequencing Results for Cancer

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Advanced cancer, Active treatment, Positive genetic test, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different types of genomic sequencing (GS) results affect cancer patients. It examines both primary GS results, which relate directly to the patient's cancer, and incidental results that may reveal other health risks. The study will explore how these results impact patients' stress levels, lifestyle changes, and healthcare costs. It seeks participants who have cancer, have had negative genetic tests for cancer mutations, and are not currently undergoing active cancer treatment.

As an unphased trial, this study offers a unique opportunity to contribute to understanding the broader impacts of genomic sequencing on cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on active cancer treatment like chemotherapy or radiation, you cannot participate. If you are on Prophylactic Hormonal Therapy, you can still join the trial.

What prior data suggests that genomic sequencing is safe for cancer patients?

Research has shown that receiving unexpected genetic test results is generally safe for patients. One study found that sharing these results with adult cancer patients did not cause harmful levels of stress or anxiety, indicating that patients managed the news of their unexpected findings well. Additionally, doctors provided follow-up care based on the test results, demonstrating that the process is managed with care and support. Overall, the research suggests that the treatment is well-tolerated, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genomic sequencing for cancer because it offers personalized insights that standard treatments like chemotherapy, radiation, and surgery don't provide. Unlike these traditional options, genomic sequencing can reveal specific genetic mutations in a patient's cancer, allowing for more targeted therapy decisions. Moreover, this method can uncover incidental genomic findings, offering additional health insights beyond the primary cancer diagnosis. This personalized approach aims to improve treatment outcomes and patient care by tailoring interventions to an individual's unique genetic makeup.

What evidence suggests that this trial's genomic sequencing results could be effective for cancer?

Research shows that genomic sequencing (GS) can help diagnose diseases and guide cancer treatment. In this trial, participants in one arm will receive GS results related to their primary cancer indication and can choose to learn about incidental findings, which might indicate risks for other health issues. Studies suggest that learning about these unexpected results can be cost-effective for some patients. Those who discover these findings may take more steps to lower their health risks. Although this technology is relatively new, the potential benefits of GS, including these unexpected findings, could be valuable for managing health. ^{1 2 6 7 8}

Who Is on the Research Team?

Yvonne Bombard, PhD

Principal Investigator

St. Michael's Hospital and University of Toronto

Are You a Good Fit for This Trial?

Adult cancer patients who speak and read English, have previously had inconclusive or negative results from specific genetic tests for cancer mutations (like BRCA1/2), and are considered candidates for genomic sequencing by their healthcare provider.

Inclusion Criteria

You can understand and communicate in English.

I have cancer.

My genetic test for cancer risk came back negative or unclear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genomic Sequencing and Result Return

Participants' genomes will be sequenced and interpreted. Results will be returned by a genetic counselor.

4-6 weeks

1 visit (in-person) for result return

Follow-up

Participants are monitored for psychological distress, clinical utility, and economic impact of genomic sequencing results.

1 year

Multiple assessments over the year

Long-term Follow-up

Assessment of long-term costs and health outcomes associated with genomic sequencing results.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• GS Results for Primary Indications only
• Incidental Genomic Sequencing Results

Trial Overview This trial is studying the effects of receiving incidental genomic sequencing results in addition to primary disease-related findings. It compares the psychological impact, health behaviors, clinical utility, and economic costs between those who get extra incidental findings and those who don't.

How Is the Trial Designed?

Group I: Incidental Genomic Sequencing Results Experimental Treatment 1 Intervention

Patients in Intervention will receive GS results related to primary indication (cancer) and will be offered the option learning their incidental results, categorized into five "bins" based on a framework by Berg et al.

Group II: Primary Indication only Active Control 1 Intervention

Patients in the control will receive the intervention GS results for Primary Indications only.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6797333/

Health outcomes, utility and costs of returning incidental ... We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03597165?term=NCT03597165&rank=1

Study Details | NCT03597165 | Incidental Genomics Patients in Intervention will receive GS results related to primary indication (cancer) and will be offered the option learning their incidental results, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25394171/

The cost-effectiveness of returning incidental findings from ... Conclusion: Returning incidental findings is likely cost-effective for certain patient populations. Screening of generally healthy individuals is likely not ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025001261

Costs and cost-effectiveness of returning secondary ... Purpose. To assess costs and cost-effectiveness of returning additional findings from genome sequencing using data from the 100,000 Genomes Project (100kGP).

5. nature.com nature.com/articles/gim2014156

The cost-effectiveness of returning incidental findings from ... Returning incidental findings is likely cost-effective for certain patient populations. Screening of generally healthy individuals is likely not ...

6. nature.com nature.com/articles/s41431-022-01069-y

Preferences for return of germline genome sequencing ... The aim of this study was to discern preferences for return of results by cancer patients who have actually undergone GS.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021044531

Oncologists' and cancer patients' views on whole-exome ... The majority of patients want most cancer-related and incidental WES results. Patients' low levels of genetic knowledge and oncologists' inexperience with large ...

8. gimopen.org gimopen.org/article/S2949-7744(24)00568-5/fulltext

Returning all clinically relevant findings from genomic ... These trial findings demonstrate that returning all clinically relevant results from GS in an adult cancer population was psychologically safe, and effective.