TargetCancer Foundation (TCF) is a 501(c)(3) non-profit rare cancer research and patient support foundation, based in Cambridge, MA. TCF was founded in 2009 by Paul Poth, after his diagnosis with cholangiocarcinoma at age 38. After Paul’s death, his family and friends continued the mission that Paul started by funding basic research into otherwise understudied rare cancers, and directly supporting patients facing the unique challenges of rare cancers. In recent years, TargetCancer Foundation has expanded its efforts by developing studies such as TRACK that more directly impact patients while simultaneously driving research forward.

TRACK is sponsored, developed and managed by TargetCancer Foundation. More information about the study team, including the academic investigators, can be found here.

TRACK is open to patients 18 years or older in the United States who have been diagnosed with a rare cancer, or cancer of unknown primary. Patients can enroll in the study at any time after their diagnosis, provided they meet the full inclusion criteria.

The study will enroll 400 patients: 100 patients with cholangiocarcinoma, 100 patients with cancer of unknown primary, and 200 patients with any other rare cancer (solid tumor or lymphoma). A list of rare cancers can be viewed here.

Comprehensive genomic profiling is carried out by Foundation Medicine, a laboratory that is licensed to provide this information, based in Cambridge, MA. Tissue will be tested using the FoundationOne® CDx platform, and blood will be tested using the FoundationOne® Liquid CDx platform.

Both the FoundationOne tissue and liquid (blood) tests have been approved by the Food and Drug Administration (FDA) as diagnostic tests to identify patients who may benefit from certain cancer treatments. Neither patients nor their insurance companies will be responsible for the costs of these tests.
 
In addition, by leveraging their regularly-scheduled, routine doctors’ appointments and blood draws, the TRACK study was designed to avoid generating additional costs for patients. Routine visits and tests may still subject TRACK patients to standard costs, co-pays or insurance charges, as they would regardless of whether or not someone participated in the study.

For TRACK, rare cancers are considered to be those affecting less than 6 per 100,000 people per year in the United States. Based on the 2020 United States population, that’s just under 20,000 people per year. A list of rare cancers can be viewed here.

No. TRACK is designed to utilize existing stored tumor tissue from prior biopsy or surgery (within the past 18 months) that was performed as standard of care.

The TCF study team will work with the patient’s treating institutions and/or medical office to facilitate the transfer of tumor tissue for comprehensive genomic profiling.

No. The TCF study team will work with patient’s treating medical institutions/medical offices to secure medical records. This will only happen with written permission from the patient.

Yes. TRACK does not exclude patients who are already participating in another clinical trial.  However, patients should check with their physician or the study investigator of their current clinical trial to make sure that it permits participation in TRACK as well.

No. TRACK is designed to allow patients to continue being treated by the doctor of their choice. Regardless of geographic location, the TRACK Virtual Molecular Tumor Board will provide individualized, patient-specific treatment recommendations to the patient’s treating physician. The patient’s physician makes all treatment decisions.

By utilizing an optional remote consenting process, TRACK allows patient enrollment and participation without requiring travel to a physical (location-specific) enrolling academic medical center or medical office, enabling full participation from geographic areas that are often not served by clinical studies, and also enabling patients to continue being treated by their local physician.

TRACK utilizes genomic testing to identify alterations in blood and tumor tissue which may be driving the growth of cancer, and can potentially be targeted using precision medicine treatments. This is different than genetic testing, which looks at inherited (or germline) alterations to determine an individual’s risk for developing a particular disease or disorder.

How long a patient is enrolled in the study will depend on when they enroll. All enrolled patients will be in the study for at least one year. However, patients that enroll early in the study (the summer of 2020) can stay in the study for up to approximately two years, as the study will stay open for one year beyond the time of enrollment of the last patient enrolled.

The TRACK study is limited to patients in the United States for a number of scientific, clinical and regulatory reasons. TargetCancer Foundation understands the impact that rare cancers have worldwide, and is hopeful that follow-on research studies to TRACK may encompass patients not residing within the United States.

TRACK initially requires that participants be able to read and understand an informed consent form that is written in English. TargetCancer Foundation understands the impact that rare cancers have in all people, and as the study moves forward to next phases, there may be documents in other languages in order to better engage all patients impacted by rare cancers.