Genetic Testing for Inherited Cancer Risk

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

27500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.

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 data supports the effectiveness of genetic testing for inherited cancer risk?

Genetic testing can help identify individuals at risk for certain cancers, allowing for tailored screening and prevention strategies. It also aids in selecting effective treatment options based on genetic information, as seen in breast cancer management, where it informs risk evaluation and treatment decisions. ^{1 2 3 4 5}

Is genetic testing for inherited cancer risk safe for humans?

Genetic testing for inherited cancer risk is generally considered safe, as it involves analyzing DNA to identify mutations and does not involve any physical intervention or treatment that could cause harm. ^{3 4 6 7 8}

How does genetic testing for inherited cancer risk differ from other treatments for cancer?

Genetic testing for inherited cancer risk is unique because it focuses on identifying genetic mutations that increase the likelihood of developing cancer, rather than treating cancer itself. This approach allows for early detection and preventive measures for individuals at high risk, which is different from traditional cancer treatments that target the disease after it has developed. ^{8 9 10 11 12}

Research Team

Jackilen Shannon, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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

I am 18 years old or older.

COHORT B: Creation of secure Medable account

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Genetic testing. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Genetic Testing in Clinical Settings. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Genetic testing for cancer susceptibility. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Advances in Genetic Testing for Hereditary Cancer Syndromes. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Cases in Precision Medicine: The Role of Tumor and Germline Genetic Testing in Breast Cancer Management. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Genetic diagnostics of cancer diseases]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Genetics as a tool to improve cancer outcomes: ethics and policy. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Hereditary cancer syndromes in gynecology: what the practitioner needs to know!]. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Genetic predisposition to cancer--issues to consider. [2006]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

[Limitations of genetic testing in oncology]. [2009]

12. Norway pubmed.ncbi.nlm.nih.gov

[Hereditary cancer]. [2008]