Project Inherited Cancer Risk Research Study – Genetic Test for Cancer
Project Inherited Cancer Risk is a groundbreaking clinical study at UK HealthCare that helps our young patients comprehend their – and their family’s – risk for cancer.
The purpose of Project Inherited Cancer Risk is to identify young patients with gene changes that increase the risk for cancer. This research study offers every pediatric cancer patient at Kentucky Children’s Hospital access to DNA sequencing to look for more than 80 inherited cancer genes. If one of those genetic markers comes back positive, Kentucky Children’s Hospital and the UK Markey Cancer Center can develop an individualized care plan for that young person and their family.
About 5 to 10 percent of families are predisposed to cancer because of a gene that doesn’t work properly. Although cancer itself cannot be passed down from generation to generation, genetic changes that increase your cancer risk can be inherited. It’s important to note that inheriting one of these genetic changes does not definitively confirm that someone will eventually be diagnosed with cancer.
Dr. John D'Orazio, chief of the Pediatric Division of Hematology/Oncology at Kentucky Children’s Hospital, is the principal investigator of this study.
By identifying the prevalence and types of cancer predisposition syndromes, we can offer you the most up-to-date and complete care. This includes providing monitoring and assessment to catch cancers as early as possible to foster the best long-term outcome.
What is required for the study?
Typically, only two tubes of blood are required for a genetic test for cancer risk. We will get this blood sample when you or your family member is already having blood drawn for lab tests. Rarely, if a blood sample isn’t possible, we will send non-tumor tissue, like a skin sample. We can obtain this sample during an already planned surgical procedure.
Results from this laboratory DNA test will fall into one of three categories: positive, negative or variant of uncertain significance. Here’s what each result means:
- Positive result: This means a genetic mutation was found.
- Negative result: This means no genetic mutation was found.
- Variant of uncertain significant result: This means a genetic mutation was found, but more information about the genetic change is needed.
We will help you understand your results and map out next steps, keeping your and your family’s well-being in mind.
What are the study's goals?
We have several goals for Project Inherited Cancer Risk:
- We will conclude whether a pediatric cancer patient in the study is affected by a known genetic predisposition to cancer. Genetic testing for cancer can determine if someone has an increased risk of developing a variety of different types of cancers. If test results reveal a cancer predisposition syndrome, we will refer you to our Pediatric and Young Adult Cancer Predisposition Clinic. This clinic is part of the DanceBlue Hematology & Oncology Clinic. This program specializes in providing care to patients and families affected by inherited cancer predisposition syndromes. The clinic’s multidisciplinary team consists of:
- Pediatric hematologists and oncologists
- Cancer genetic counselors
- Nurses and nurse navigators
- Nutrition experts
- School intervention specialists
- Social workers
- Child life specialists
- An additional arm of this study available to our families involves pharmacogenomic testing. This tells us how the body processes or metabolizes certain medicines. Testing helps us predict medicine side effects and provide more precise treatment.
- Finally, with consent, we would like to store a blood sample in the UK Markey Cancer Center for future research. This helps us learn how to better treat children and young adults with cancer in the future.
Who can participate in the study?
We offer genetic screening for cancer risk to children and young adults who get their oncology care through the DanceBlue Pediatric Hematology & Oncology Clinic at Kentucky Children’s Hospital. We can perform genetic testing for cancer on patients with a history of pediatric cancer regardless of current age.
Who cannot participate in the study?
You will not be able to take part in the study if you are not able to consent to Project Inherited Cancer Risk.
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.
What is involved and where will the study take place?
The research procedures and lab tests will be conducted at the DanceBlue Pediatric Hematology & Oncology Clinic and the UK Markey Cancer Center. We expect that samples needed for this research will be drawn when you are here receiving your regular cancer care.
Do I have to pay to be in the study?
No. Neither study participants nor their insurance company will be billed for participation in this study.
What will I be asked to do?
To take part in Project Inherited Cancer Risk, a patient or their 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. The medical treatment participants or their families receive for cancer will not be affected by whether or not they take part in this study.
Our patients will always discuss with their doctors the treatment plan that is best for them. Everything you will be asked to provide for this research will occur during your regular cancer care.
Who can I contact if I have further questions?
Contact Dr. John D’Orazio at jdorazio@uky.edu or 859-257-4554 at any time if you have any questions or concerns about Project Inherited Cancer Risk.
The University of Kentucky’s Institutional Review Board (IRB) has reviewed and approved this study. The IRB is a group of people who review research studies to protect the rights and welfare of research participants. You can call the Office of Research Integrity at UK if you:
- Have questions about your rights as a research participant
- Are not able to resolve your concerns with the study doctor
- Have a complaint or general questions about what it means to be in a research study
The Office of Research Integrity is available from 9 a.m. to 5 p.m. ET weekdays at 859-257-9428 or toll-free at 1-866-400-9428.
