Apply to Trial

Compensation: Varies

Number of Visits: 2

1000 Participants Needed

Genetic Counseling for Cancer Risk

Overseen ByBanu Arun

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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?

To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.

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 data supports the effectiveness of the treatment Genetic Testing and Counseling for cancer risk?

Research shows that genetic counseling and testing can identify individuals at higher risk for hereditary cancer, allowing for targeted prevention and early detection strategies, which can reduce illness and death from cancer. This approach is especially effective when combined with education and personalized risk management, ensuring patients understand the benefits and implications of genetic testing.¹ ² ³ ⁴ ⁵

Is genetic counseling for cancer risk safe?

Genetic counseling and testing for cancer risk are generally considered safe, but there have been reports of errors when performed by clinicians without specialized training, which can lead to negative outcomes for patients and their families.¹ ² ⁶ ⁷ ⁸

How is the treatment Genetic Testing and Counseling different from other treatments for cancer risk?

Genetic Testing and Counseling is unique because it focuses on identifying individuals at risk for hereditary cancer before diagnosis, allowing for targeted prevention and management strategies. Unlike other treatments that address cancer after it develops, this approach uses genetic information to guide decisions and reduce cancer risk proactively.¹ ² ³ ⁸ ⁹

Research Team

Banu Arun

Principal Investigator

MD Anderson Cancer Cneter

Eligibility Criteria

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

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

Treatment Details

Interventions

Genetic Testing and Counseling
Screening Form

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Screening FormExperimental Treatment1 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 CounselingExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

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]

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]