RADIANT is an observational research study that uses self-reported information, your medical records, doctor-reported information, and a few drops of blood to better understand radiation therapy and cancer. RADIANT is sponsored by DxTerity Diagnostics, a Los Angeles based genomics company. DxTerity is developing a blood test to be used by future patients before they begin radiation therapy to provide doctors with information about a person’s likely response to radiation treatment.
Participating is easy! RADIANT is designed for you to do from the comfort of your home.
Cancer patients 18 years or older that are scheduled to begin, but have not started, radiotherapy treatment to their abdominal-pelvic area are eligible to participate. Following the completion of a short, on-line qualification questionnaire and an informed consent form, eligible individuals are enrolled. Additionally, we will request permission to contact your doctor(s) and look at your medical records.
Participants will be sent four (4) fingerstick blood collection kits, and they will also be asked to answer a short health survey to track their individual response to radiotherapy. Check out the FAQ “What is the DxCollect kit?” to learn more about the kit! The kits and questionnaire are to be completed at the following time points:
1. Before you start your radiation treatment
2. In the middle of radiation treatment
3. Near or shortly after the end of radiation treatment
4. About 6 weeks after radiation treatment is completed
Each kit is crucial for researchers to better understand your response to radiation treatment.
Participating in clinical research is an important part of discovering new ways of treating disease. Volunteers, like you, are the reason medical research moves forward. People join clinical research studies for a number of reasons, but the most common reason is to help future patients.
Before you get your first DxCollect kit, you will need to read and sign the informed consent form. When you click “Join Now,” a link to RADIANT’s electronic informed consent form (eConsent) will be emailed to you. Check out the FAQ “What is Informed Consent?” for more information.
After you consent, we will call you to confirm your shipping address, so we can mail your first DxCollect kit. You can expect your first kit within 3 to 5 days of confirming your shipping address.
You will also get access to a secure RADIANT study portal. In your RADIANT study portal, you will register your kits and answer questions throughout the study. Information you share with us will be secured within the portal for your privacy.
Informed consent is an important process in clinical research. The person (participant) who is joining a research study is given facts about the study so they can decide whether or not to participate. The informed consent process is designed to protect participants, like you, by telling you about a study before you decide to participate. Informed consent is required by law to make sure participants joining a study fully understand (are informed about) the clinical research study before starting. A consent form answers questions you may have such as:
- What is the study about?
- What will I be asked to do during the study?
- How long will I be in the study?
- Are there possible risks or benefits to participating?
- How will my information be kept private?
- If I start the study, can I decide not to be in the study later?
- Who can I contact about the study?
Signing a consent form means you agree to participate in the research study. Consent for clinical research is completely voluntary, and you may change your mind at ANY time during the study if you no longer want to participate.
RADIANT has a consent form that must be read and signed before you can begin the study. When you click “Join Now,” you will be emailed a link. Please read and sign the consent form online.
A clinical trial is a scientific process that studies the safety and usefulness of new devices, diagnostics, and drugs intended for people. Clinical trial patients are given the drug or device to determine if it works as planned.
An observational clinical study, like RADIANT, does not test a new drug or device and does not provide medical treatment. Observational studies collect information and samples from participants to support the development of new products.
The DxCollect kit is used by study participants to collect and preserve very small amounts of blood for analysis of DNA and RNA. The blood is collected from the participant’s finger using a lancet (pricker), similar to blood glucose testing.
After pricking their finger, the participant drips approximately 5 drops of blood into the collection sponge contained at the tip of a blue collection device. Once the sponge is full, the collection device is screwed into a white transport tube, and the sample is returned to DxTerity in the pre-labeled, pre-postage paid box that it arrived in.
DxTerity is sponsoring the RADIANT study. DxTerity is a Los Angeles based diagnostics company that specializes in the development of blood-based genomic tests.
RADIANT is studying cancer and abdominal-pelvic radiation treatment. In order to accomplish this, only people who have been diagnosed with one of the cancers listed on the Do You Qualify page can participate at this time.
The information that you provide, your medical record information, and your genomic testing information will be used by researchers to study the relationship between an individual and their response to radiation therapy.
Your data will be de-identified and coded; this means researchers will not have access to your name or other personal information that can identify you. Your personal information will be kept in a private and confidential manner.
Your privacy is extremely important to us. Information you share during RADIANT is handled and maintained in a confidential manner.
All health information you and your doctor/healthcare provider share with RADIANT will be maintained within a secure study portal. Before your data is used by the researchers, information that could be used to directly identify you is removed, so your identity is kept private.
We will not return lab results or genetic data to you. Information collected for RADIANT will be used for research only and patient specific information will not be provided.
For your time and participation, you will be paid $100 for completing ALL of the study activities, including answering health questionnaires, completing fingerstick kits, and providing access to your medical records. All study items must be completed to receive the payment, and there will be no partial payments provided for partially completed study items. You can choose either a Visa rewards card or to have DxTerity donate $100 to the American Cancer Society.
No, there are no costs to you.
Researchers will use information from your medical records to confirm your cancer diagnosis, medications, and medical history.
Your care is important to us and so is the relationship you have with your doctor. We want to make sure that your doctor is aware that you are involved in our study. We encourage you to let your doctor know you have joined RADIANT, and we will provide you a welcome letter to give to your doctor.
Your doctor is invited to contact RADIANT to learn more about the study and participate by answering a few questions about your cancer treatment.
We will provide you a welcome letter to give to your doctor. This letter explains what RADIANT is and how your doctor can contact us for more information. You can also print the Informed Consent Form to take to your doctor, as well as direct them to this website, www.radiantstudy.com. You and your doctor may contact RADIANT if you have any additional questions about the study.