27500 Participants Needed

Genetic Testing for Inherited Cancer Risk

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: OHSU Knight Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.34678

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.89101112

Research Team

JS

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
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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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Screening (genetic testing)Experimental Treatment4 Interventions
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Find a Clinic Near You

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

References

Genetic testing. [2019]
Genetic Testing in Clinical Settings. [2019]
Genetic testing for cancer susceptibility. [2018]
Advances in Genetic Testing for Hereditary Cancer Syndromes. [2016]
Cases in Precision Medicine: The Role of Tumor and Germline Genetic Testing in Breast Cancer Management. [2020]
Accurate genetic testing platform based on haploid templates: Use in inheritable colon cancer. [2010]
[Genetic diagnostics of cancer diseases]. [2013]
Genetics as a tool to improve cancer outcomes: ethics and policy. [2017]
[Hereditary cancer syndromes in gynecology: what the practitioner needs to know!]. [2006]
Genetic predisposition to cancer--issues to consider. [2006]
11.Czech Republicpubmed.ncbi.nlm.nih.gov
[Limitations of genetic testing in oncology]. [2009]
[Hereditary cancer]. [2008]