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Incidental Genomic Sequencing Results for Cancer

N/A
Waitlist Available
Led By Yvonne Bombard, PhD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Or received a negative/inconclusive germline panel test result
18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years following return of results.
Awards & highlights

Study Summary

This trial will evaluate whether patients who receive incidental genomic sequencing results will have higher levels of distress and more risk-reducing behaviors compared to patients who only receive sequencing for their primary indication.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There are no direct physical side effects from receiving genomic sequencing results. However, participants may experience psychological distress or anxiety upon learning about potential inherited risks for other diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My genetic test for cancer risk came back negative or unclear.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years following return of results.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years following return of results. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital Anxiety and Depression Scale (HADS)
Secondary outcome measures
Adapted Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire
Genetic Self Efficacy (GSE)
Impact of Event Scale-Revised (IES-R)
+5 more
Other outcome measures
Cascade genetic testing among relatives
Cascade health behaviors among relatives
Clinical actions triggered by genomic sequencing results
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Incidental Genomic Sequencing ResultsExperimental Treatment1 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 onlyActive Control1 Intervention
Patients in the control will receive the intervention GS results for Primary Indications only.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,476 Total Patients Enrolled
Yvonne Bombard, PhDPrincipal InvestigatorSt. Michael's Hospital and University of Toronto
2 Previous Clinical Trials
266 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BMJ OpenJournal
Health Outcomes, Utility and Costs of Returning Incidental Results from Genomic Sequencing in a Canadian Cancer Population: Protocol for a Mixed-methods Randomised Controlled Trial
Shickh, Salma, Marc Clausen, Chloe Mighton, Mariana Gutierrez Salazar, Kathleen-Rose Zakoor, Rita Kodida, Emma Reble, et al.. 2019. “Health Outcomes, Utility and Costs of Returning Incidental Results from Genomic Sequencing in a Canadian Cancer Population: Protocol for a Mixed-methods Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-031092.
clinicaltrials.govStudy
Incidental Genomics
2018. "Incidental Genomics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03597165.
~43 spots leftby Apr 2025
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