NCT04504604 TCF-001 TRACK (Target Rare Cancer Knowledge) Study
| NCT ID | NCT04504604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TargetCancer Foundation |
| Condition | Rare Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2020-10-01 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.
Eligibility 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.
Contact & Investigator
Razelle Kurzrock, M.D.
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT04504604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rare Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04504604 currently recruiting?
Yes, NCT04504604 is actively recruiting participants. Contact the research team at track@targetcancer.org for enrollment information.
Where is the NCT04504604 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT04504604 clinical trial?
NCT04504604 is sponsored by TargetCancer Foundation. The principal investigator is Razelle Kurzrock, M.D. at Medical College of Wisconsin. The trial plans to enroll 400 participants.
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