What is CHROME?
CHROME stands for CHRonic fatigue syndrOME and is an observational research study that that uses participant’s health information, a few drops of blood, and a urine sample to better understand what it means to live with and manage CFS. CHROME is sponsored by DxTerity Diagnostics, a Los Angeles based genomics company. DxTerity researchers are looking to find a better, easier, and more convenient way for people living with CFS to be properly diagnosed and effectively treated.
Everyone’s experience living with CFS is personal, from your diagnosis to your symptoms, and your treatment. By collecting your unique health history, daily experiences, and blood and urine samples from the convenience of home, CHROME is working to personalize the next generation of CFS management, so that those diagnosed with CFS will have the knowledge and power to live confidently.
How do I participate?
Participating is easy! CHROME is designed for you to do from the comfort of home. You do not have to visit a doctor’s office or clinic to participate.
After you click Join Now we will email you a link to download an App, where you will confirm your eligibility and provide Informed Consent for the study . During CHROME, you’ll be asked to complete questionnaires about your health and medical history. The questionnaires will be available within your secure CHROME study app. You can access this app at any time from your tablet or smartphone.
We will also ask you to collect a few drops of blood using our DxCollect® Fingerstick kit, as well as provide a urine sample. Kits will be mailed to your home, and we’ve already paid the postage so all you need to do is drop your kit off for overnight shipping.
Will I need to change my current medications or treatment plan to participate?
No! As a member of CHROME, you will not have to change anything about your daily routine. CHROME is an observational research study designed to collect real world information and samples from participants. CHROME does not test a new drug or device and does not provide medical treatment. Through CHROME, participants have the freedom to be involved in CFS research without having to change anything about the medications they are currently taking or treatment they are receiving.
Why should I participate?
Participating in clinical research is an important part of discovering and developing new medicines and diagnostic tools. Participants, like you, are the reason medical research moves forward. People join research studies for many reasons, but the most common reason is to help future patients and to move medical science forward. By joining CHROME, you will help contribute to CFS research that may result in better ways of diagnosing and managing the disease.
I signed up. Now what?
before your first DxCollect® kit is mailed, you will need to read and sign the Informed Consent Form. When you click Join Now link to download an App, where you will confirm your eligibility and provide Informed Consent for the study . During CHROME, you’ll be asked to complete questionnaires about your health . Check out the FAQ What is Informed Consent? for more information.
After you submit the eConsent:
You can expect your kit within 3 to 5 business days of confirmation of your shipping address. If you are selected for a second collection, this will be mailed to you 1-2 weeks following your first collection.
– You will get access to your secure CHROME study App. In your CHROME study App, you will register your kits and answer questions throughout the study.
What is informed consent?
CHROME 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 to download an App, where you will consent for the study. During CHROME, you’ll be asked to complete questionnaires about your health.
What is the difference between a clinical trial and an observational research study?
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.
CHROME is an observational research study that does not test a new drug or device and does not provide medical treatment. Observational studies collect information and samples from participants, like you, to support the understanding of medical conditions and development of new products.
What is the DxCollect® kit?
The DxCollect® kit was developed by DxTerity, to be used by participants to collect small amounts of blood for DNA and RNA analysis. The DxCollect® is designed to preserve DNA and RNA at room temperature for long periods of time, allowing us to ship our kits all around the country.
Who is conducting this study?
DxTerity is sponsoring the CHROME study. DxTerity is a Los Angeles-based research company that uses state of the art technologies to analyze DNA and RNA. They also developed the DxCollect® Kit (used in CHROME) for easy at-home collection of fingerstick blood samples. DxTerity will be analyzing the samples and information collected during CHROME to better understand the signs and symptoms of CFS, improving diagnostics and treatment options.
What is genomics?
Genomics includes the study of how genes interact with each other and with the environment. Genomics looks at both DNA and RNA . Your genomic information can change in response to your disease or from environmental conditions. Genomics can provide information on what is happening in your body right now and why researchers are looking to develop tests using this information.
I don’t have Chronic Fatigue Syndrome (CFS). Can I participate?
CHROME is studying CFS. In order to accomplish this, only people who have been diagnosed with CFS can participate at this time. If you would like to participate and do not have diagnosed CFS then we may include you in our comparator branch. You will receive a stipend for your participation. In the future, DxTerity may sponsor new research studies that you may qualify for. We encourage you to check back with DxTerity about future studies at firstname.lastname@example.org!
What will happen to my information and samples?
The health information you share with CHROME will be used to help researchers understand results from your blood and urine samples in terms that translate into diagnostic disease markers, daily disease activity and what it means to live with CFS. Translating lab data into clinical outcomes is important to ensure new treatment options may be available for patients.
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.
Is my information kept private?
Your privacy is very important to us. Information you share during CHROME is handled and maintained in a confidential manner.
All health information that you share with CHROME will be maintained within a secure study database. Before your data is used for research, information that could be used to directly identify you is removed, so your identity is kept private.
Will I get test results?
We will not return lab results or genetic data to you. Information collected for CHROME will be used for research only and participant-specific information will not be provided.
Will I get paid?
For your time and participation, you will be paid with a $50 rewards card for completing ALL DxCollect® kits and required questionnaires. There is no compensation for partially completed study activities.
Does it cost anything?
No, there are no costs to you.
Why do you need my medical records?
Researchers will use the information from your medical records to confirm the results of our study. Your medical records will help us to better understand how your health history links with your health condition.