Genetic Testing for Hereditary Cancer Risk

Overseen By Arun Banu, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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: 2

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify individuals at risk for hereditary cancers, such as breast and colorectal cancer, through genetic testing and counseling. It focuses on helping women prevent, detect early, or receive personalized treatment for these cancers. Women visiting mobile units for mammograms are ideal candidates, as they will have access to genetic screening services. Participants will use a saliva collection kit and complete a form to assess their cancer risk. As an unphased trial, this study provides participants with valuable insights into their genetic health and encourages proactive cancer prevention steps.

Do I need to stop my current medications for this trial?

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

What prior data suggests that genetic testing and counseling is safe?

Research shows that genetic testing and counseling are generally safe. Studies have found no evidence of harm from genetic counseling. This process involves gathering a family's medical history to help assess cancer risk. It's non-invasive, requiring no surgery or entry into the body. Participants only need to provide a saliva sample for testing. This simplicity makes genetic testing easy to handle, with no reports of negative effects. Overall, it is a safe option for those seeking to understand their inherited cancer risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the genetic testing and counseling approach for hereditary cancer risk because it provides a personalized assessment of an individual's genetic predisposition to cancer, which is not typically available through regular screenings. Unlike traditional methods that rely mostly on family history and basic screenings, this approach uses advanced genetic analysis from a simple saliva sample to identify specific mutations associated with hereditary cancers. This method not only offers a more precise risk assessment but also empowers individuals with knowledge about their genetic health, potentially leading to more informed decisions about their healthcare and prevention strategies.

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

Research has shown that genetic testing and counseling, provided to participants in this trial, can identify individuals at risk for inherited cancers. Studies indicate that this process helps individuals understand their cancer risk based on family history and personal genetics. This understanding can lead to personalized prevention and treatment plans, improving early detection and potentially saving lives. Additionally, genetic counseling offers valuable education and emotional support, aiding people in making informed health decisions. Overall, genetic testing and counseling serve as effective tools for managing the risk of inherited cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Arun Banu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women scheduled for mammograms with Project VALET's mobile units. It aims to identify those at risk of hereditary cancers like ovarian, breast, and colorectal cancer by providing genetic screening and counseling.

Inclusion Criteria

Any woman scheduled at Project VALET mammography screening mobile units will be eligible for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Genetic Testing and Counseling

Participants will be given a saliva collection kit for hereditary cancer and genetic testing, including standard paperwork and instructions for sample collection and shipping.

4 weeks

1 visit (in-person)

Education

Provide education to providers and patients regarding hereditary cancers using IRB approved educational material and short video.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after genetic testing and counseling

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing and Counseling

Trial Overview The study tests the effectiveness of using mobile mammography units to offer genetic testing and counseling services. The goal is to see if this approach helps in early detection or personalized treatment planning for hereditary cancers.

How Is the Trial Designed?

Group I: Screening Form Experimental Treatment 1 Intervention

Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers.

Group II: Genetic Testing and Counseling Experimental Treatment 1 Intervention

Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing. The kit includes all standard paperwork and instructions for collecting the sample and shipping the kit back to the genetic testing company (Invitae).

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

Approved in United States as Genetic Counseling and Testing for:

• Hereditary breast cancer
• Hereditary ovarian cancer
• Hereditary colorectal cancer
• Other hereditary cancers

Approved in European Union as Genetic Counseling and Testing for:

• Hereditary breast cancer
• Hereditary ovarian cancer
• Hereditary colorectal cancer
• Other hereditary cancers

Approved in Canada as Genetic Counseling and Testing for:

• Hereditary breast cancer
• Hereditary ovarian cancer
• Hereditary colorectal cancer
• Other hereditary cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Community Outreach and Engagement Fund for Underserved Texans

Collaborator

Trials

1

Recruited

1,000+

Published Research Related to This Trial

The complexity of hereditary cancer risk assessment and testing is increasing due to advancements in understanding genetic factors, highlighting the need for specialized training in this area.

Surgical oncologists play a crucial role in identifying patients with hereditary cancer syndromes who may benefit from genetic counseling and assessment, emphasizing the importance of collaboration with genetic counselors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic risk assessment, counseling and testing. Rich, TA., Salazar, M.[2009]

Cancer genetic counseling and testing are crucial for identifying individuals and families at risk for hereditary cancers, allowing for targeted management strategies that can reduce cancer-related morbidity and mortality.

Effective cancer genetic services require informed consent and pretest counseling to ensure individuals understand the implications of genetic testing, and collaboration among healthcare providers is essential to navigate the increasing complexity of testing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying hereditary cancer: genetic counseling and cancer risk assessment. Lewis, KM.[2014]

The integration of hereditary cancer genetic counseling units (HCGCUs) into Spanish hospitals provides high-quality, multidisciplinary care for individuals and families at risk of hereditary cancers.

The Spanish Society of Medical Oncology (SEOM) has established guidelines to ensure the effective operation and quality control of HCGCUs, aiming to enhance patient care and coordination in managing hereditary cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SEOM recommendations on the structure and operation of hereditary cancer genetic counseling units (HCGCUs). Lastra-Aras, E., Robles-Díaz, L., Guillén-Ponce, C., et al.[2021]

Mainstreaming genetic testing into routine cancer care has shown to improve the uptake of testing among patients, which is crucial for managing hereditary cancer risks, especially in breast and gynecologic cancers.

Despite the success of mainstreaming, there is a concern that comprehensive genetic risk assessments are often overlooked, potentially missing opportunities for preventive care and tailored screening for patients at increased cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic risk assessment in breast and gynecologic malignancies- what's to know in 2024? Kamara, D., Silver, E., Niell-Swiller, M.[2023]

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]

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]

About 10% of cancer patients may have a hereditary predisposition, highlighting the importance of genetic testing for identifying susceptibility genes.

Understanding genetic test results can aid in creating effective cancer prevention and early detection plans, emphasizing the need for nurses to be knowledgeable about genetic resources and hereditary cancer syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common hereditary cancer syndromes. Greco, KE., Mahon, S.[2019]

Cancer Risk Assessment and Counseling services provide valuable benefits beyond genetic testing, including risk assessment, education on cancer causes, and support for psychosocial issues related to cancer.

Families, regardless of their cancer history, can gain significant advantages from these services, emphasizing that genetic testing should be viewed as a helpful tool rather than the main focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will cancer risk assessment and counseling services survive genetic testing? Kelly, PT.[2019]

Genetic testing for hereditary cancer risk is crucial for implementing personalized surveillance and prevention strategies, which can significantly save lives.

The article emphasizes the importance of genetic counselors in the testing process and provides guidance for physicians on how to identify patients who should be referred for genetic cancer risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer genetic counseling: when to refer for cancer risk assessment and genetic testing. Kunz, B., Marty, D., Baker-Lange, K.[2012]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK65817/

Cancer Genetics Risk Assessment and Counseling (PDQ®) Cancer genetics risk assessment and genetic counseling includes family history, psychosocial assessments, and education on hereditary cancer ...

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

Hereditary Cancer Genetic Testing: 30 Years of Impact on ... Hereditary cancer genetic counseling provides personalized risk-assessment, patient education, and psychosocial counseling. Those at increased ...

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.gov cancer.gov/publications/pdq/information-summaries/genetics/risk-assessment-hp-pdq

Cancer Genetics Risk Assessment and Counseling (PDQ®) Cancer genetics risk assessment and genetic counseling includes family history, psychosocial assessments, and education on hereditary cancer ...

7. stanfordhealthcare.org stanfordhealthcare.org/medical-treatments/c/cancer-risk-assessment-genetic-testing-counseling.html

Cancer Genetic Testing and Counseling Our genetic testing and counseling provide the expertise you need for assessing your hereditary cancer risk. We have experience with rare gene mutations.

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. sutterhealth.org sutterhealth.org/services/genetic-testing-counseling

Genetic Testing and Counseling for Cancer Risk Our trusted genetic counselors provide guidance on the practical, medical and emotional aspects of genetic testing.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12043037/

Call to action for genetic counseling research in hereditary ... While the evidence does not suggest harm from genetic counseling, considering the differences between the variety of cancer types and genetic ...