Genetic Testing for Inherited Cancer Risk

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Under 18, No genetic counseling, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how offering free genetic testing to the general public can help identify individuals with inherited cancer risks, such as those related to breast, ovarian, or Lynch syndromes. The goal is to determine if testing everyone, not just high-risk families, is beneficial. Participants will provide saliva samples for genetic testing, and if results are positive, they will receive genetic counseling. Individuals diagnosed with any type of cancer in the past year or with a history of certain genetic variants (such as BRCA1 or BRCA2) are well-suited for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could benefit a wider population.

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 identifying inherited cancer risk?

Research has shown that genetic testing for inherited cancer risk is generally safe. The main step involves collecting a saliva sample, which poses no physical harm.

However, other types of risks may arise. Some individuals might feel stressed about their results, while others could worry about the impact on their family. Concerns about privacy or the cost of follow-up care may also exist.

Before deciding to undergo testing, consulting a genetic counselor is advisable. A counselor can explain what the test can and cannot reveal and help you understand how the results might affect you and your family. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic testing for inherited cancer risk because it provides a proactive approach to cancer prevention. Unlike traditional methods that focus on treatment after cancer develops, genetic testing identifies individuals at higher risk, allowing for early intervention and personalized care. This method uses saliva samples for analysis, making it a non-invasive and accessible option for patients. Additionally, if a genetic risk is detected, patients can receive targeted genetic counseling, which helps them understand their risks and make informed decisions about their health.

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

Studies have shown that genetic testing can accurately identify individuals at risk for inherited cancer conditions, such as hereditary breast and ovarian cancer or Lynch syndrome. Research indicates that early knowledge of these genetic risks enables doctors to develop personalized monitoring and treatment plans, potentially improving health outcomes. Genetic testing for cancer risk has become more accurate and affordable, facilitating the detection of potential issues before they become serious. Despite its benefits, many eligible individuals, particularly among minority groups, do not undergo genetic testing. This trial will involve participants in genetic testing to help close that gap and increase awareness of cancer risk. ^{1 6 7 8 9}

Who Is on the Research Team?

Jackilen Shannon, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults who may or may not have cancer but are interested in genetic testing for inherited cancer syndromes like BRCA1, BRCA2, and Lynch syndrome. It's open to those who've had genetic counseling within the last five years or an encounter within the past year. Participants need to consent and create a secure account for data collection.

Inclusion Criteria

COHORT C: Consent to the HOP repository, either hard or electronic signature

COHORT B: Creation of secure Medable account

I have genetic mutations in BRCA1, BRCA2, or Lynch syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing

Participants undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Up to 5 years

Follow-up

Participants are monitored for adherence to standard of care and effectiveness of genetic testing over time

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing

Trial Overview The study offers free genetic testing to the public and collects biospecimens. It includes surveys and genetic counseling to understand the benefits of widespread testing for hereditary cancers versus only high-risk families.

How Is the Trial Designed?

Group I: Screening (genetic testing) Experimental Treatment 4 Interventions

Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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]

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]

Genetic testing can help identify inherited mutations that increase cancer risk, allowing for early diagnosis and management of the disease in affected individuals and their family members.

By screening family members for these inherited mutations, it is possible to detect potential cancer risks before symptoms appear, which can lead to better prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate genetic testing platform based on haploid templates: Use in inheritable colon cancer. Papadopoulos, N.[2010]

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 research is enhancing the ability to identify inherited cancer risks, which necessitates careful evaluation of the benefits and potential harms of genetic testing.

To effectively implement genetic testing in clinical practice, guidelines and educational strategies must be developed to keep pace with advancements in knowledge, ensuring equitable access to genetic services for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetics as a tool to improve cancer outcomes: ethics and policy. Burke, W., Press, N.[2017]

Genetic testing for cancer syndromes can help identify high-risk gene carriers, which is useful for predicting cancer risks and guiding preventive care, but non-carriers in families with known mutations may still have different risk levels than the general population.

Testing for genes associated with mild or moderate cancer risk is not recommended in clinical practice due to potential misinterpretations, and the quality of molecular genetic testing can vary based on technology and understanding of mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Limitations of genetic testing in oncology]. Foretová, L., Navrátilová, M., Machácková, E.[2009]

Advancements in understanding the genetic basis of inherited cancers are leading to improved predictive genetic testing, which can help identify individuals at risk.

Multidisciplinary research, including insights from the Human Genome Project, is crucial for developing guidelines and recommendations for genetic testing and cancer prevention on a global scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic predisposition to cancer--issues to consider. Malkin, D., Knoppers, BM.[2006]

Only 10% of cancer cases are inherited, highlighting the importance of expert genetic counseling to assess individual and familial risks associated with genetic testing.

Identifying germline mutations can help determine specific lifetime cancer risks and enable tailored preventive and therapeutic strategies targeting the underlying genetic causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Genetic diagnostics of cancer diseases]. Cobilanschi, J.[2013]

A significant portion of cancers are linked to inherited genetic factors, including monogenic cancer syndromes and autosomal recessive syndromes, highlighting the importance of genetic predisposition in cancer development.

The growing identification of cancer-susceptible genes allows for the advancement of genetic testing, which can help in predicting cancer risk, although it also presents challenges and ethical considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hereditary cancer]. Børresen-Dale, AL., Boman, H.[2008]

Genetic testing for cancer-related mutations is becoming more accessible in general healthcare, moving beyond specialized genetic services.

Surgeons play a crucial role in identifying patients who may benefit from genetic testing and can adjust their treatment plans based on the test results, enhancing personalized cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing for cancer susceptibility. Calzone, KA., Soballe, PW.[2018]

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]

Genetic testing in breast cancer treatment helps personalize care by providing crucial information for both germline and tumor testing, which aids in risk evaluation and treatment options.

Discussions about hereditary cancer genetic testing should cover potential results, management strategies, and concerns about privacy and discrimination, highlighting the role of genetic professionals in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cases in Precision Medicine: The Role of Tumor and Germline Genetic Testing in Breast Cancer Management. Tischler, J., Crew, KD., Chung, WK.[2020]

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/PMC10765765/

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

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. 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 ...

5. 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.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK236037/

Genetic Testing and Assessment - NCBI - NIH Assessment of the molecular basis for inheritance is done by examining the specific structure and function of genetic material, or DNA. Locating a disease- ...

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

What are the risks and limitations of genetic testing? There are different kinds of risks involved with genetic testing. These include physical, emotional, social, or financial.

8. cancer.org cancer.org/cancer/risk-prevention/genetics/genetic-testing-for-cancer-risk/what-happens-during-genetic-testing-for-cancer.html

What Happens During Genetic Testing for Cancer Risk? The first step in genetic testing is to collect information about your personal and family medical history. This may be done by a genetic counselor.

9. beonbrand.getbynder.com beonbrand.getbynder.com/m/4a3b7b4f4e88470d/original/Genetic-and-Molecular-Diagnostics-Testing-for-Inherited-Cancer-Risk.pdf

Testing for Inherited Cancer Risk Candidates for genetic testing may wish to consult with a genetics professional who can explain in detail the benefits, risks, and limitations ...