Project Inherited Cancer Risk Research Study
Project Inherited Cancer Risk helps you comprehend your – and your family’s – risk for cancer.
The purpose of this study is to identify young patients with gene changes that increase cancer risk. By determining the prevalence and types of cancer predisposition syndromes in our patients, we can help provide them the most up-to-date and comprehensive care.
What is required?
Typically, only two tubes of blood, which we get when you or your family member is already having blood drawn for lab tests. Rarely, if a blood sample can’t be arranged, we would send non-tumor tissue, like a skin sample, that can be obtained during a planned surgical procedure.
What are the study's goals?
There are several goals for this study:
1. We will determine whether you or your family carries a known cancer predisposition syndrome that increases the likelihood of developing cancer. If a cancer predisposition syndrome is found, we would refer you to our multidisciplinary Cancer Predisposition Clinic, which specializes in the care of patients and families affected by inherited cancer predisposition syndromes.
2. An additional arm of this study you can opt into involves pharmacogenomic testing. This would tell us how your body processes or metabolizes certain medications to help us predict medication side effects and provide better treatment.
3. Another optional arm of the study is to test for “actionable health genes.” Mutations in these genes have data-driven interventions which can decrease morbidity and/or mortality. Some of these genes are associated with cancer, and others are associated with other known medical conditions such as cardiovascular disease. If a mutation is found in one of those genes, we would refer you to a genetics counselor and relevant specialists.
4. Finally, with your permission, we would like to store a blood sample in the UK Markey Cancer Center for future research to help us learn how to better treat children and young adults with cancer in the future.
Who can participate?
We are offering genetic testing to pediatric and young adult cancer patients who get their oncologic care through the DanceBlue Pediatric Hematology & Oncology Clinic at Kentucky Children’s Hospital.
Who cannot participate?
Anyone who isn’t a pediatric and young adult cancer patient being treated in the DanceBlue clinic, anyone who is older than 29 and anyone who already has a diagnosis of an inherited cancer syndrome.
What kind of study is this?
This is a prospective observational cohort study evaluating clinical outcomes of germline cancer genetic testing in the DanceBlue Pediatric Hematology & Oncology Clinic at Kentucky Children’s Hospital.
What is involved and where will the study take place?
The research procedures will be conducted at the DanceBlue Pediatric Hematology & Oncology Clinic and/or the Kentucky Children’s Hospital. We anticipate that the samples needed for this research will be drawn when you are here receiving your regular cancer care.
Will you have to pay to be in the study?
No. Neither you nor your insurance company will be billed for participating in this study.
What will you be asked to do?
To take part, you or your parent/guardian will need to understand this study and agree to participate by signing a “Research Informed Consent/Parental Permission/Authorization” form. This is not a treatment study, and the medical treatment you or your family receives for cancer will not be affected whether or not you take part in this study.
You and your doctor will always decide the best treatment for you. Everything we ask you to donate for this research would be available from and taken during your regular cancer care.
Who can you talk with if you have further questions?
The University of Kentucky’s Institutional Review Board has reviewed and approved this study. The Institutional Review Board is a group of people who review research studies to protect the rights and welfare of research participants. If you have questions about your rights as a research participant, if you are not able to resolve your concerns with the study doctor, or if you have a complaint or general questions about what it means to be in a research study, you can call the Office of Research Integrity at the University of Kentucky between 5 a.m. and 5 p.m. EST Monday through Friday at 859-257-9428 or toll-free at 1-866-400-9428.