The ongoing challenges presented by the COVID-19 pandemic have interrupted and altered medical research across the globe. While some scientists have had to halt their studies abruptly, others can forge ahead thanks to virtual options.
The chordoma community is one of many rare disease communities invited to participate in one such study, the Natural History Study of Rare Solid Tumors, currently underway at the National Cancer Institute (NCI). The purpose of this study is to collect information, data, and tissue and tumor samples from patients with rare solid tumors, such as chordoma, to understand better how these tumors develop and grow. Studies like this one help researchers learn more about rare cancers and inform the development and design of clinical trials to test new therapies.
Unlike trials to test treatments, natural history studies don’t test the safety or efficacy of therapies for disease. Instead, they compile information from a large number of patients to better understand — as the name implies — the “history” of a disease over a long period of time. Researchers use natural history study data to look for trends and get new ideas on how to treat rare cancers. Patients who take part in these studies help speed up the development of new treatments by giving researchers the information they need to make progress.
Natural history studies are considered very safe because participants are not exposed to any experimental treatments. For chordoma patients, one of the benefits of participating in this natural history study is the opportunity to visit the NIH through either the specialty chordoma clinic, held once a year, or at any other time through the weekly rare tumor clinic. An advantage to the specialty chordoma clinic, is not only the chance to connect with experts who have extensive experience with chordoma, but to meet other patients or parents of patients with chordoma. Another option is the ability to participate from wherever you are, without needing to travel to the NIH. This is especially valuable in our current environment of social distancing as it is an excellent opportunity to contribute to research without leaving home.
“Any chordoma patient, including those in active treatment, is welcome to participate in the Natural History Study from the comfort of their home,” said Dr. Brigitte C. Widemann, Chief of the Pediatric Oncology Branch at NCI’s Center for Cancer Research. “Patients participating in this study will make critical contributions to our understanding of rare tumors and the development of effective therapies for these tumors.”
Interested in learning more or participating? Here’s what you need to know.
How do I participate in the study?
First, NCI will collect medical records and imaging from you or your physician to be reviewed by the study team. They will also collect samples of your tumor that may be available from a prior biopsy or surgery. You will be asked to 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, all of which you can do online from home or through paper forms the NCI will mail 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.
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 to collect the medical documentation required for participation. While this may extend the enrollment process, the Natural History study team remains committed to this research and continues to work remotely to consent and engage new patients. Once you send an initial email to the NCI team to find out information about the study, they aim to respond to you within 24-48 hours.
How will my samples be used?
Your saliva and tumor samples will be used to perform genetic testing. NCI will combine your data with data from other people with chordoma. If they collect blood, they will 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?
No, not all results will be returned to you. Because some of the genetic testing performed is for research purposes, 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 disease are identified in your tumor samples, 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.
Can I receive chordoma treatment while participating in this study?
Yes. You can receive chordoma treatment while participating in the Natural History Study, but you will not receive treatment through the study itself as it is not a treatment trial. You can continue to receive care recommended by your provider or participate in an ongoing clinical trial. 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 trials enrolling chordoma patients, visit our Clinical Trials Catalogue..
Do I have to travel to the NIH Clinical Center to participate?
No. You can provide your saliva sample and other information from home. However, based on a review of your medical records, you may be invited to the NIH Clinical Center at a future date to meet with experts who will perform additional tests and answer any questions you have.
How can I learn more or enroll in the study?
How does the Natural History Study relate to the Chordoma Foundation Tumor Donation Program (Biobank)?
They are separate research projects, each serving a distinct and important purpose. Participation in both projects is possible. You can enroll in the NCI Natural History Study if you are interested in doing so whether or not you have previously contributed tumor tissue to the Chordoma Foundation Biobank. 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 temporarily on hold)