The chordoma community is one of a number of rare cancer communities that has been invited to participate in the Natural History Study of Rare Solid Tumors, currently underway at the U.S. National Cancer Institute (NCI). The purpose of this important study is to...
Natural History Study of Rare Solid Tumors
You can help improve treatment options for chordoma
Researchers at the U.S. National Cancer Institute (NCI) are currently enrolling chordoma patients in a Natural History Study of Rare Solid Tumors. Clinical and biological information collected by the study, including tumor tissue samples, will provide a better understanding of how chordomas develop and grow, and how we can more effectively treat them.
Natural history studies compile information from a large number of patients to better understand the “history” of a disease over a long period of time. This study will provide us with a comprehensive, detailed understanding of the natural course of chordoma from the time it forms, to when it first causes symptoms, and through every clinical stage after that.
Why this study is important
Knowledge of the natural history of chordoma is critical to the process of getting treatments approved for chordoma. Researchers will use data from this natural history study to gain new insights into the biology of chordoma and develop treatments that are more tailored to chordoma. Additionally, we must be able to demonstrate that new treatments change the natural history of chordoma in order for them to be approved — having this baseline data will make it possible to meaningfully assess the effect of new treatments in clinical trials.
Who can participate
Chordoma patients and survivors anywhere in the world and at any stage of treatment — before, during, or after — are able to enroll. Because this is an informational study and not a treatment study, participants are not required to visit the National Institutes of Health (NIH) Clinical Center in person. Pediatric patients over the age of 1 year can be enrolled in the study by their parent or guardian.
How the study works
Once you send an initial email to the study team to learn more about the study, they aim to respond to you within 24-48 hours. As with all clinical studies, there is a screening process you must go through before you enroll. The team at NCI will collect certain medical records, provide you with more information about the study, answer any questions you may have, and then inform you of your rights as a study participant (informed consent).
See “What can I expect while participating in the study?” below for details about the process after you enroll.
Why should I participate?
Because your participation will help researchers understand chordoma better so that new treatments can be identified, developed, and, ultimately, approved. You can join the study safely and easily from wherever you are in the world, with no travel required. This is especially valuable in our current environment of travel restrictions and social distancing as it is an excellent opportunity to contribute to research without leaving home.
You may also have the opportunity, if you wish, to visit the NIH Clinical Center (after current restrictions are lifted) through either the specialty chordoma clinic, held once a year, or at any other time through the weekly rare tumor clinic. If you participate in the chordoma clinic you will have the chance to connect with experts who have extensive experience with chordoma and meet other patients and families dealing with chordoma.
Are natural history studies safe?
Natural history studies are considered very safe because participants are not exposed to any experimental treatments.
What can I expect while participating in the study?
First, the NCI team will collect your medical records and imaging from you or your physician. They will then contact the hospital(s) where you had prior biopsy or surgery to request samples of your tumor tissue. When the hospital receives the request, they will arrange to have your tumor sample sent directly to NCI. Once you’ve signed forms to release your tumor tissue, the NCI team will do the rest.
You will be sent a kit in the mail that you will use to collect and send a saliva sample to NCI. Additionally, you will be asked to fill out questionnaires about your medical history, your family’s medical history, and how having a rare tumor impacts your life. These forms are available online and do not have to be completed all at once. You will be able to save your progress and then return to complete them as you are able. If you prefer not to complete the forms on the computer, the team will mail paper forms to you.
Based on a review of your medical records, you may be invited to the NIH Clinical Center (after current restrictions are lifted) to meet with experts who will perform additional tests and answer questions. You may also be invited to participate in focus groups about how living with a rare tumor affects your life. All participants will receive an annual follow-up form from NCI to record any changes in their health.
I don’t live in the United States. Can I still participate?
Yes! Any chordoma patient anywhere in the world is welcome to participate, as in-person visits are not required by this study. Due to privacy rules and other factors it may take longer for the team at NCI to acquire your medical records and tumor sample, but they will continue working until they have everything they need.
How will COVID-19 impact this process?
With so many hospitals and medical centers focused on caring for COVID-19 patients, it may take longer than usual for the Natural History Study team to collect the medical documentation required for participation (for example, a pathology report confirming a diagnosis of chordoma). While this may extend the enrollment process, the study team is committed to this research and continues to work diligently to consent and enroll new patients.
How will my samples be used?
Saliva and tumor samples, collected on all participants, will be used to perform genetic testing. NCI will combine your data with data from other people with chordoma. If you do go to the NIH Clinical Center, they will collect blood to look at what kinds of cells and molecules are in your bloodstream that might affect your tumor. They will also look at immune cells in your tumor samples. Your samples may also be stored for future research. NCI may share the information they learn with other scientists while protecting your privacy to allow many researchers to work on new treatments for chordoma.
Will all of my genetic testing results be returned to me?
Not all results will be returned to you. Because some of the genetic and other testing is currently performed for research purposes only, it is not the same type of testing that can be ordered by a doctor through a clinical laboratory. If clinically actionable mutations associated with your chordoma are identified in your tumor sample, the NCI study team will contact you and your doctor and suggest, if needed, that you have the results confirmed by a clinical genetic testing laboratory. The NCI has genetic counseling resources to help you understand this information.
Do I have to travel to the NIH Clinical Center?
No. You can provide your saliva sample and other information from home, so traveling is not required. However, based on a review of your medical records, you may be invited to visit the NIH Clinical Center at a future date (once restrictions are lifted), if you wish, to meet with experts who will perform additional tests and answer any questions you have.
Can I participate in this study while I’m being treated for chordoma?
Yes. You will not receive treatment through this study as it is not a treatment trial, but you can receive care recommended by your chordoma provider or participate in an ongoing clinical trial while participating in the Natural History Study. If the study team is aware of any clinical trials you may be eligible for, they will help you learn more about those trials. For more information about treatment trials enrolling chordoma patients, visit our Clinical Trials Catalogue.
I have already donated tumor tissue to the Chordoma Foundation’s Biobank. Is this study the same thing?
No. They are separate research projects, each serving a distinct and important purpose, and participation in both projects is possible. If you previously contributed tumor tissue to the Chordoma Foundation Biobank, that tumor sample cannot be shared with the NCI at this time. You will need to enroll in this NCI study separately if you are interested in participating. If you participate in the NCI study now and have surgery again in the future, you can elect to contribute to the CF Biobank at that time. (Please note that new tumor donations to the Biobank are currently on hold. Click here for more information.)
If you have more questions about this study or other clinical trials that may be options for chordoma patients, please contact a Chordoma Foundation Patient Navigator.
Last month, on April 16-18, the first-ever chordoma-specific clinic for pediatric and young adult patients was held at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. Conducted in collaboration with the My Pediatric and Adult Rare Tumor...
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