Genetic Testing for Cancer Prevention

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Prisoners, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genetic testing can improve cancer screening and treatment for Indigenous American communities in the Southwest. Researchers aim to understand genetic changes in cancer cells to prevent and treat cancer more effectively in these populations. Participants will provide blood, saliva, and tissue samples for testing and will receive their genetic testing results along with guidance for future care. The trial seeks cancer patients or survivors who self-identify as Indigenous American. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could enhance cancer care for their communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that genetic testing is safe for cancer prevention?

Research shows that genetic testing is generally safe. This process examines a person's DNA, which acts like a set of instructions for how the body functions. Studies have found that genetic testing can identify risks for certain diseases, leading to personalized health advice and prevention plans. Importantly, the test itself poses no known physical risks, as it typically involves collecting blood, saliva, or tissue samples in a non-harmful manner. Overall, genetic testing is well-tolerated, with few to no negative effects reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic testing for cancer prevention because it offers a personalized approach to identifying cancer risks. Unlike traditional methods, which usually rely on family history and routine screenings, genetic testing analyzes an individual's DNA to detect specific mutations that may increase cancer risk. This allows for earlier and more precise interventions, tailored specifically to each person's genetic profile. By providing results that inform personalized counseling and care, this method has the potential to significantly enhance preventive strategies and outcomes.

What evidence suggests that genetic testing is effective for cancer prevention in Indigenous American populations?

Research shows that genetic testing, which participants in this trial will undergo, can identify cancer risks and guide treatment. Studies have found that this testing can detect gene changes that might cause cancer. This information helps create personalized screening and prevention plans. For Indigenous American communities, who often face challenges in accessing healthcare, such testing could lead to earlier detection and improved health outcomes. While genetic testing is already enhancing cancer care, it promises even more personalized treatment in the future. ^{3 6 7 8 9}

Who Is on the Research Team?

Jewel Samadder, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for Indigenous American individuals from the Southwest who are affected by cancer. It aims to study genetic changes in their cells to enhance cancer screening and treatment outcomes within these communities, which face significant health disparities.

Inclusion Criteria

I am currently receiving cancer treatment or have survived cancer.

Self-identify as Indigenous American

Exclusion Criteria

Prisoners

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Genetic Testing

Participants undergo collection of blood or saliva samples and leftover tissue for genetic testing. Results are returned with resources for counseling and further care.

Ongoing during study participation

Follow-up

Participants are monitored annually for up to 5 years to assess outcomes and provide ongoing support.

Up to 5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing

Trial Overview The JUNIPER Trial involves survey administration, genetic testing of tumors, biospecimen collection, and a communication intervention to understand how these approaches can help prevent and treat cancer more effectively in Indigenous American populations.

How Is the Trial Designed?

Group I: Screening (blood, saliva, tissue collection, genetic testing) Experimental Treatment 4 Interventions

Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.

Genetic Testing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Genetic Testing for:

• Ovarian cancer
• Endometrial cancer
• Breast cancer
• Colorectal cancer
• Other hereditary cancers

Approved in European Union as Genetic Testing for:

• Ovarian cancer
• Endometrial cancer
• Breast cancer
• Colorectal cancer
• Other hereditary cancers

Approved in Canada as Genetic Testing for:

• Ovarian cancer
• Endometrial cancer
• Breast cancer
• Colorectal cancer
• Other hereditary cancers

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+

Published Research Related to This Trial

Genetic testing plays a crucial role in screening, diagnosing, and guiding drug therapy for diseases with a genetic basis, but there are challenges in its widespread clinical application due to the limited number of actionable genetic variants.

To enhance the use of genetic information in healthcare, there is a need for improved health literacy among providers and the public, as well as addressing ethical and social issues related to genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Testing in Clinical Settings. Franceschini, N., Frick, A., Kopp, JB.[2019]

The introduction of a highly predictive genetic test for breast cancer could complicate ongoing prevention trials by increasing noncompliance among participants, but it also opens up opportunities to design new trials focused on individuals at very high risk of developing cancer.

These new trial designs could potentially reduce the size, duration, and cost of cancer prevention studies, while emphasizing the continued importance of randomized trials for evaluating effective prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential impact of genetic testing on cancer prevention trials, using breast cancer as an example. Baker, SG., Freedman, LS.[2019]

Recent advancements in cancer molecular genetics have made genetic testing feasible, allowing individuals at risk to receive personalized cancer screening and prevention strategies.

Genetic counseling is crucial for interpreting test results and managing the psychosocial impacts of genetic risk assessments, ensuring patients understand the implications of their results in relation to their cancer experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing. Petersen, GM.[2019]

The Cancer Risk Evaluation Program effectively addresses the complexities of presymptomatic genetic testing for cancer susceptibility, providing comprehensive services including genetic counseling, risk analysis, and long-term surveillance for individuals concerned about their cancer risk.

Participant evaluations indicate that the program meets the needs of those seeking genetic testing, while also adhering to established guidelines and ethical considerations in cancer genetic services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a cancer risk evaluation program. Calzone, KA., Stopfer, J., Blackwood, A., et al.[2009]

Genetic testing for cancer risk has advanced significantly, allowing for targeted cancer screening and prevention strategies for individuals with identified genetic predispositions, which is now considered good medical practice in many cases.

However, the benefits of genetic testing can vary, necessitating careful evaluation of its costs and benefits, as well as the effectiveness of any subsequent interventions, highlighting the need for structured systems to manage testing demand and educate the public and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs, benefits and limitations of genetic testing for cancer risk. Ponder, BA.[2009]

The establishment of satellite clinics and educational programs significantly improved clinician knowledge about cancer genetic counseling, leading to better quality referrals for patients, with 88% of patients attending their appointments.

In a predominantly Latina clinic population, 71.4% of patients had cancer, and 17 families were identified with genetic mutations, indicating that targeted genetic counseling can effectively identify at-risk individuals and potentially reduce cancer morbidity in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. Ricker, C., Lagos, V., Feldman, N., et al.[2022]

Genetic tests are popular among consumers, but they come with significant uncertainties and potential inaccuracies, which insurers are cautious about.

Positive results from these tests can trigger a series of costly and possibly risky follow-up diagnostic procedures, raising concerns about their overall value and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the Gene Genie. Greene, J.[2018]

Genetic testing for cancer-predisposition genes can predict future health risks, benefiting not only individuals but also their families by providing crucial health information.

The implications of genetic testing extend beyond medicine, raising important ethical and social issues such as informed consent, confidentiality, and potential genetic discrimination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controversies and ethical issues in cancer-genetics clinics. Harris, M., Winship, I., Spriggs, M.[2014]

Genetic testing has become a key tool in personalized medicine, allowing for the identification of mutations that increase cancer risk and enabling tailored strategies to minimize these risks.

The advancements in genetic testing technology since the Human Genome Project have improved the ability to test more patients for cancer predispositions, highlighting the need for healthcare professionals to be knowledgeable about genetics to ensure safe and effective use of these tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Genetic Testing for Hereditary Cancer Syndromes. Thomas, E., Mohammed, S.[2016]

Genomic testing in cancer care helps identify the most effective treatment options for individual patients, potentially ruling out unnecessary chemotherapy, which can be costly and not suitable for everyone.

By ensuring that treatments are tailored to the patient's specific genetic profile, genomic testing can improve patient outcomes while also reducing overall healthcare costs and resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genomic testing in oncology to improve clinical outcomes while optimizing utilization: the evolution of diagnostic testing. Collymore, DC., Kobilis, SL., Lundquist, TG., et al.[2017]

Recent advancements in molecular genetics have enabled genetic testing for inherited mutations linked to cancer, although these mutations account for only 5-20% of all cancers, highlighting the complex nature of the disease.

Identifying inherited cancer syndromes and providing predictive genetic testing and counseling are crucial for women and families at increased risk, but discussions about the best practices for early detection and prevention are ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hereditary cancer syndromes in gynecology: what the practitioner needs to know!]. Kuschel, B., Köchli, OR., Niederacher, D., et al.[2006]

Genetic screening for disease predisposition is becoming more common due to advancements in technology, offering valuable insights into individual health risks.

However, there are significant concerns about the potential misuse of genetic information by employers and insurance companies, leading to calls for legal protections to prevent discrimination based on genetic data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic information privacy and discrimination. Goldberg, IV.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10765765/

Genetic Testing for Successful Cancer Treatment - PMC Genetic testing for cancer-related disorders has significantly improved in accuracy and affordability, potentially revolutionizing monitoring ...

2. 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.

3. 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.

4. med.stanford.edu med.stanford.edu/news/all-news/2023/06/genetic-testing-cancer.html

Few patients receive recommended genetic testing after ... A new study finds surprisingly low genetic testing rates for cancer patients who may benefit, especially among Asian, Black and Hispanic patients.

5. medrxiv.org medrxiv.org/content/10.1101/2025.07.07.25331048v1.full-text

Genetic testing in cancer: a systematic review of patient ... This review has identified, described and summarised what types of measures have been used when patients with cancer have undergone genetic ...

6. mayoclinic.org mayoclinic.org/tests-procedures/genetic-testing/about/pac-20384827

Genetic testing Genetic testing involves examining your DNA, the chemical database that carries instructions for your body's functions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843151/

Understanding Genetic Screening: Harnessing Health ... Genetic screening analyzes an individual's genetic information to assess disease risk and provide personalized health recommendations.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2211335522000882

Are beliefs about the importance of genetics for cancer ... Identifying carriers of pathogenic variants through genetic testing can inform preventive strategies such as prophylactic surgery and intensified screening for ...

9. web.musc.edu web.musc.edu/inourdnasc

In Our DNA SC In Our DNA SC offers no cost genetic screening and ancestry results to drive preventative health care for the people of South Carolina.