Genetic Counseling for Cancer Risk

Overseen By Banu Arun

Age: 18+

Sex: Any

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 help Black individuals understand their risk of hereditary breast and colorectal cancers through genetic testing and counseling. Participants first fill out a screening form to assess their cancer risk, then provide a saliva sample for genetic testing. The trial suits Black or African-American adults interested in learning more about their cancer risk and management. As an unphased trial, it offers a unique opportunity for participants to gain personalized insights into their genetic health.

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

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

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

Research has shown that genetic testing and counseling are generally safe. Genetic counseling involves discussing family history with a counselor to understand the risk of inherited cancers. This process is manageable and carries no direct physical risks.

Genetic testing typically requires a saliva sample, which is simple and non-invasive. Concerns often focus on the emotional impact of learning about cancer risk, rather than physical side effects. However, genetic testing remains a common and safe method for assessing cancer risk in most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic counseling and testing for cancer risk because it offers a personalized approach to cancer prevention. Unlike traditional screenings that rely on age or family history alone, this method uses genetic information from a simple saliva sample to assess risk more accurately. This can empower people with tailored strategies for monitoring and reducing their cancer risk, potentially catching hereditary cancers like breast and colorectal cancer earlier than ever before.

What evidence suggests that this trial's treatments could be effective for assessing cancer risk?

Research shows that genetic testing and counseling, a treatment arm in this trial, can identify individuals at risk for inherited cancers. This process helps individuals understand their cancer risk and take steps to manage it. Studies indicate that genetic counseling provides crucial information about cancer risk and aids patients in making informed health decisions. Reviews and analyses suggest that these services improve understanding and reduce anxiety about cancer risks. Overall, genetic testing and counseling serve as valuable tools for preventing and managing cancer. Another arm of this trial involves completing a screening form to assess the risk of hereditary breast and colorectal cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Banu Arun

Principal Investigator

MD Anderson Cancer Cneter

Are You a Good Fit for This Trial?

This trial is for Black or African-American individuals over the age of 18 living in Houston, Texas. Participants must be willing to sign a 'Permission to Contact' form consenting to join the study.

Inclusion Criteria

I am over 18, identify as Black or African-American, and have signed the consent form.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Genetic Testing and Counseling

Participants will be given a saliva collection kit for hereditary cancer and genetic testing, followed by genetic counseling if necessary

4-6 weeks

1 visit (in-person or virtual) for sample collection, additional visits for counseling as needed

Follow-up

Participants are monitored for safety and effectiveness after genetic testing and counseling, including family cascade testing if applicable

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing and Counseling
• Screening Form

Trial Overview The trial aims to use a simple genetic risk screening tool and telegenetics (remote genetic counseling) to connect participants with their hereditary cancer risks for conditions like colorectal and breast cancer.

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. You will be asked to provide your: * Name and contact information (including your address, phone number, and email) * Demographic information (including your age, race, and ethnicity) * Health insurance status * Annual household income * Personal and family history of cancer, including diagnosis and age at diagnosis

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.

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+

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 services are essential for assessing hereditary cancer risks and providing tailored management options, requiring expertise from clinicians trained in both oncology and genetics.

Genetic counselors and nurses play a crucial role in these services, as they are equipped to conduct risk assessments, educate patients, and offer psychosocial support, which can ultimately help reduce cancer-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling and clinical cancer genetics services. Stopfer, JE.[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]

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]

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]

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]

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]

Cancer genetic counseling and testing are crucial in cancer care, but there are significant risks when these services are provided by clinicians without specialized training in genetics.

The review highlights national cases of errors in genetic counseling that have led to adverse outcomes, impacting medical liability, healthcare costs, and the well-being of patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cancer genetic testing: medical, ethical, legal, and financial implications. Brierley, KL., Blouch, E., Cogswell, W., et al.[2013]

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]

Citations

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

Cancer Genetics Risk Assessment and Counseling (PDQ®) This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about cancer genetics risk ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37688462/

Systematic evidence review and meta-analysis of outcomes ... Purpose: Genetic counseling (GC) is standard of care in genetic cancer risk assessment (GCRA). A rigorous assessment of the data reported from published studies ...

4. 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.

5. 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.

6. kucancercenter.org kucancercenter.org/outreach/prevention/genetic-counseling-testing

Genetic Counseling & Testing Genetic testing provides information about your risk factors for specific hereditary types of cancer, which include: Breast cancer · Colon cancer · Ovarian ...

7. 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 ...

8. marylandoncology.com marylandoncology.com/treatments-services/genomic-testing/cancer-genetic-risk-assessment/

Cancer Genetic Risk Assessment - Maryland ... Through hereditary risk assessment, we can help you learn about your inherited risk of developing cancer, such as breast, gastrointestinal, uterine/ovarian and ...