Targeting rare cancers with genomic therapy
TCF-001 TRACK (Target Rare Cancer Knowledge) Study
This study is testing if personalized treatments based on the genetic makeup of rare tumors can help patients feel better and improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TargetCancer Foundation Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT04504604 on ClinicalTrials.gov |
What this trial studies
This open label, non-randomized, multi-center study aims to determine if patients with rare tumors can benefit from personalized molecular therapy based on their next-generation sequencing results. Participants will undergo comprehensive genomic profiling of their tumors and plasma DNA, with findings analyzed by a Virtual Molecular Tumor Board. The board will provide treatment recommendations to the treating physicians, who will make the final treatment decisions. The study allows for remote participation and traditional site-based enrollment across the United States.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with rare solid tumors or lymphomas that have evaluable disease.
Not a fit: Patients with common cancers or those whose tumors do not meet the rare cancer criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide tailored treatment options for patients with rare cancers, potentially improving their outcomes.
How similar studies have performed: Other studies utilizing genomic profiling for targeted therapies in rare cancers have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Provision of signed and dated informed consent form. * Stated willingness to comply with all study related blood draws and assessments for the duration of the study. * Individuals who are 18 years old or older at the time of consent. * Patients with a rare (fewer than 6 cases per 100,000 per year) solid tumor or lymphoma with evaluable disease at baseline. The complete list of included cancers are included in the study protocol; diseases not listed in the study protocol may be enrolled with the approval of the Principal Investigator. * May or may not have had qualifying (by Foundation Medicine) comprehensive genomic profiling before the present study. For those who have had qualifying comprehensive genomic profiling performed prior to the present study, the archival specimen tested must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study. * Willingness to provide existing archived and/or newly collected tissue resulting from standard of care procedures and blood samples for genomic profiling. If the submitted sample is determined to be insufficient for testing, the patient will be considered to be a screen failure. * For archival tissue to be used for comprehensive genomic profiling for the present study, that specimen must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study. * Willingness to provide clinical and medical information to the study team as required. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Ability to read, write and communicate in English. * Ability to review and sign a web-based informed consent form, or review and sign an informed consent form in treating physician office. * Resides within the United States. EXCLUSION CRITERIA * Participants who are unable to provide informed consent. * Participants who are 17 years of age or younger. * Participants who are unable to comply with the study procedures. * Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements. * Concurrent active malignancy requiring treatment within 1 year of enrollment, at the discretion of treating physician. * Pregnancy or breastfeeding. * Any unlisted criteria at the discretion of the treating physician.
Where this trial is running
Cambridge, Massachusetts
- TargetCancer Foundation — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Razelle Kurzrock, M.D. — Medical College of Wisconsin
- Study coordinator: Mary Oster
- Email: track@targetcancerfoundation.org
- Phone: 617-299-0389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.