Genetic Testing for Cancer Risk

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hematological cancer, Bone marrow transplants, others

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

Compensation: Varies

Number of Visits: 1

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the use of genetic testing to assess cancer risk in diverse ethnic groups. Researchers will collect blood or saliva from participants to identify genetic markers that might indicate a higher chance of developing cancer. The goal is to develop personalized cancer screening strategies based on genetic risk. The trial seeks individuals diagnosed with any solid tumor cancer who identify as part of various ethnic groups, including Hispanic/Latino, Native American/Alaskan, African American, Asian, and European. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to personalized cancer prevention strategies.

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 cancer genetic testing is safe?

Research has shown that the physical risks of cancer genetic testing are very low. Most tests require only a blood or saliva sample, which are easy and safe to collect. As a result, most individuals handle the procedure well. The main concerns focus not on the physical process but on understanding the results and their implications for health. Many individuals, particularly from minority groups, seek these tests to learn more about their cancer risk and benefit from clear information. Overall, the testing process is safe and simple. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic testing for cancer risk because it offers a personalized approach to understanding an individual's likelihood of developing cancer. Unlike traditional methods that rely on family history or general risk factors, this testing examines specific genetic markers in a person's blood or saliva, providing a tailored risk assessment. This can lead to earlier interventions or preventive measures that are customized to an individual's genetic profile, potentially improving outcomes.

What evidence suggests that cancer genetic testing is effective for identifying cancer risk?

Research shows that genetic testing, which participants in this trial will undergo, can identify individuals at risk for inherited cancers. Studies have demonstrated that examining genes linked to cancer can reveal genetic changes in those with a family history of the disease. This testing provides a personalized assessment of cancer risk, guiding screening and prevention efforts. A review of studies found that genetic testing helps patients manage their health more effectively both before and after testing. With this information, genetic testing offers a promising approach for understanding and managing cancer risk. ^{1 6 7 8 9}

Who Is on the Research Team?

Jewel Samadder, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults from diverse ethnic backgrounds, including Hispanic/Latino, Native American/Alaskan, African American, Asian and European descent who have solid tumor cancers. They must be able to provide a blood sample and agree to genetic testing at Mayo Clinic in Arizona or Florida.

Inclusion Criteria

You are from certain ethnic backgrounds such as Hispanic/Latino, Native American/Alaskan, African American, Asian, and other European populations.

I have been diagnosed with a solid tumor cancer and am seeking treatment at Mayo Clinic.

I can safely provide the needed blood samples.

Exclusion Criteria

I had a genetic test with 40+ genes at Mayo Clinic in the last 2 years, and the results can be reviewed.

I have or had blood cancer, like leukemia or multiple myeloma.

I have had a bone marrow transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biospecimen Collection

Patients undergo collection of blood or saliva sample for genetic testing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for the impact of genetic testing on therapeutic management and targeted cancer prevention

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cancer Genetic Testing

Trial Overview The study focuses on collecting biospecimens and conducting genetic tests among various ethnic groups. It aims to identify cancer genes for better risk assessment and personalized screening strategies.

How Is the Trial Designed?

Group I: Screening (biospecimen collection) Experimental Treatment 2 Interventions

Patients undergo collection of blood or saliva sample for genetic testing.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. cancer.gov cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet

Genetic Testing Fact Sheet - NCI A fact sheet about genetic testing for inherited cancer risk. Includes who should consider testing, and how to understand test results.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11356586/

Hereditary Cancer Genetic Testing: 30 Years of Impact on ... A polygenic risk score uses data gleaned from genome-wide association studies to provide statistical likelihood of disease. Polygenic risk ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831135

Strategies to Assess Risk for Hereditary Cancer in Primary ... We sought to implement and evaluate universal assessment of hereditary cancer risk followed by at-home genetic testing for eligible individuals ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023009966

Systematic evidence review and meta-analysis of ... We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.

5. myriad.com myriad.com/genetic-tests/myrisk-hereditary-cancer-risk-test/

MyRisk® Hereditary Cancer Test MyRisk® Hereditary Cancer Test evaluates 48 genes associated with hereditary cancer risk to identify genetic changes in patients with a family history of ...

6. cancer.org cancer.org/cancer/risk-prevention/genetics/genetic-testing-for-cancer-risk/understanding-genetic-testing-for-cancer.html

Understanding Genetic Testing for Cancer Risk Genetic testing looks for certain mutations (changes) in a person's genes that might put them at higher risk of getting certain cancers.

7. 23andme.com 23andme.com/test-info/genetic-health/?srsltid=AfmBOoouTHtWx4YHydgeGZFpoPYKXns1jPMVp8ATGtpUkF3Iv66mJtME

Information about Genetic Health Risk reports This test includes 44 out of more than 4,000 variants in the BRCA1 and BRCA2 genes that are known to increase cancer risk.

8. medlineplus.gov medlineplus.gov/genetics/understanding/testing/riskslimitations/

What are the risks and limitations of genetic testing? The physical risks associated with most genetic tests are very small, particularly for those tests that require only a blood sample or buccal smear.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4417728/

Concerns About Cancer Risk and Experiences With ... Conclusion. Many patients, especially minorities, express a strong desire for genetic testing and may benefit from discussion to clarify risks.