1000 Participants Needed

Genetic Testing for Hereditary Cancer Risk

AB
Overseen ByArun Banu, MD
Age: 18+
Sex: Female
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

What You Need to Know Before You Apply

What is the purpose of this trial?

Identifying women at risk for hereditary cancer potentiates prevention, early detection or personalised treatment against cancer. We using mobile mammography units will provide genetic sceening and testing services to underserved women coming for thier mammograms to these units.

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.

Is genetic testing for hereditary cancer risk safe for humans?

Genetic testing for hereditary cancer risk is generally considered safe for humans, as it involves analyzing DNA to identify genetic mutations and does not involve any physical intervention or medication. However, it is important to have pretest counseling to understand the benefits, risks, and limitations of the testing.12345

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

Genetic Testing and Counseling is unique because it focuses on identifying individuals and families at risk for hereditary cancer through genetic testing and personalized counseling, rather than treating cancer itself. This approach helps in creating targeted prevention and management strategies, which can reduce the risk of developing cancer, unlike traditional treatments that address cancer after it has developed.13567

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

Genetic testing and counseling can help identify individuals at increased risk for hereditary cancer, allowing for early prevention or detection strategies, which are most effective before a diagnosis. This approach is considered a standard of care and has been shown to reduce cancer risk in high-risk individuals.13489

Who Is on the Research Team?

AB

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?
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.
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. 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:

πŸ‡ΊπŸ‡Έ
Approved in United States as Genetic Counseling and Testing for:
  • Hereditary breast cancer
  • Hereditary ovarian cancer
  • Hereditary colorectal cancer
  • Other hereditary cancers
πŸ‡ͺπŸ‡Ί
Approved in European Union as Genetic Counseling and Testing for:
  • Hereditary breast cancer
  • Hereditary ovarian cancer
  • Hereditary colorectal cancer
  • Other hereditary cancers
πŸ‡¨πŸ‡¦
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+

Community Outreach and Engagement Fund for Underserved Texans

Collaborator

Trials
1
Recruited
1,000+

Published Research Related to This Trial

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

Citations

Genetic testing. [2019]
If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. [2022]
Common hereditary cancer syndromes. [2019]
Identifying hereditary cancer: genetic counseling and cancer risk assessment. [2014]
Genetic risk assessment in breast and gynecologic malignancies- what's to know in 2024? [2023]
Will cancer risk assessment and counseling services survive genetic testing? [2019]
Cancer genetic counseling: when to refer for cancer risk assessment and genetic testing. [2012]
Genetic risk assessment, counseling and testing. [2009]
SEOM recommendations on the structure and operation of hereditary cancer genetic counseling units (HCGCUs). [2021]
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