Trial Summary
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.
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.
12345Is 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.
34567How 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.
45789Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
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:
🇺🇸 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
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
Community Outreach and Engagement Fund for Underserved TexansCollaborator
References
Genetic testing. [2019]New research developments in the molecular genetics of cancer have led to the feasibility of cancer genetic testing. At present, genetic test results can better inform individuals at risk about appropriately tailored strategies for cancer screening and prevention. In the future, more persons will be eligible for genetic evaluation; in particular, if it is shown that patients with cancer who are carriers of germline mutations respond differently to treatments, genetic testing may be warranted. Consideration needs to be given to the appropriate delivery of genetic risk assessment and testing. There is a great potential for misinterpretation of gene test results and for adverse psychosocial consequences for patients. Genetic counseling is an important component in cancer risk assessment and management, particularly in helping persons at risk understand the implications of gene test results in the context of their experience with cancer and surveillance.
If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. [2022]Cancer genetic counseling and testing is a standard of care option for appropriate families and can identify individuals at increased risk prior to diagnosis, when prevention or detection strategies are most effective. Despite documented efficacy of cancer risk reduction in high-risk individuals, underserved and minority individuals have a disproportionate cancer burden and limited access to genetic counseling.
Common hereditary cancer syndromes. [2019]To review cancer risk assessment and counseling, hereditary cancer syndrome risk factors, indicators for cancer predisposition testing, and interpretation of genetic test results.
Identifying hereditary cancer: genetic counseling and cancer risk assessment. [2014]The goal of cancer genetic counseling, risk assessment, and testing is to identify individuals and families at risk for hereditary cancer, such that targeted management strategies can be used to reduce associated morbidity and mortality. Involvement of a qualified cancer genetic service provider helps to ensure that at-risk individuals identified and offered appropriate education, risk assessment, genetic testing, and follow-up risk management strategies. There are multiple screening and hereditary risk models available to help the clinician identify who needs to be referred to cancer genetic counseling and to facilitate the cancer risk assessment process. Genetic testing should only be pursued with fully informed consent in the context of pretest counseling to ensure that the individual understands the benefits, risks, and limitations of genetic testing, possible results, and their implications. Incorporating psychosocial assessment throughout the counseling session may assist the individual in their understanding of genetic testing in the context of their support resources and coping mechanisms and may help with decision making. There is a growing public awareness of and interest in cancer genetic testing, as well as increasing complexity of available testing options and results. It is therefore essential that cancer genetic professionals, primary care providers, and oncology practitioners work together to ensure that genetic testing for hereditary cancer syndromes is used in the most appropriate and effective way.
Genetic risk assessment in breast and gynecologic malignancies- what's to know in 2024? [2023]Hereditary cancer risk assessment and counseling have become integral in oncology care, especially in breast and gynecologic malignancies where genetic test results impact management. However, a large number of patients who could benefit from genetic testing are not getting tested. As such, genetic risk assessment and counseling methods have had to evolve to meet the needs of this expanding patient population.
Will cancer risk assessment and counseling services survive genetic testing? [2019]With the availability of genetic testing to detect increased hereditary susceptibility to breast and other cancers, Cancer Risk Assessment and Counseling services have come to be viewed by many primarily as a means of obtaining genetic testing and hereditary risk information. The public and healthcare professionals need to be aware that even when genetic testing is not used or is uninformative, families with and without a strong family history of cancer will benefit from Cancer Risk Assessment and Counseling if the process includes assessment of cancer risk, information about cancer etiology, help in dealing with the psychosocial consequences of the cancer experience, and development of emotional and medical coping strategies. Risk assessment services can best serve concerned individuals and their families when sufficient time is allotted for these primary aims, and when genetic testing is seen as one of the useful tools, not the primary goal of such services.
Cancer genetic counseling: when to refer for cancer risk assessment and genetic testing. [2012]Identifying hereditary cancer risk saves lives through individualized surveillance and prevention efforts. Advances in testing technologies and genetic knowledge are providing us with new tools for identifying individuals and families who are at highest risk for cancer. This article reviews our current genetic testing abilities, describes the role of genetic counselors, and offers guidance and resources for physicians as they determine who ought to be referred for genetic cancer risk assessment and testing.
Genetic risk assessment, counseling and testing. [2009]Hereditary cancer risk assessment, counseling, and testing are becoming ever more complex as the understanding of the genetic components of disease grows. The demand for highly trained professionals with expertise in this field, such as genetic counselors, is also growing. Surgical oncologists are likely to encounter patients with hereditable cancer syndromes in their practice and should be able to identify patients appropriate for genetic assessment and counseling.
SEOM recommendations on the structure and operation of hereditary cancer genetic counseling units (HCGCUs). [2021]Approximately 5 % of all cancer cases are hereditary. Cancer genetic counseling assesses individual and family risks of cancer, conducts genetic studies, interprets results, and advises patients regarding strategies for prevention and risk reduction. Currently, many networks of hereditary cancer genetic counseling units (HCGCUs) are integrated in the medical oncology services of most Spanish hospitals, which are comprised of multidisciplinary teams and offer high-quality care for the treatment of hereditary cancer.