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TRACK Study for Rare Cancers

This study, called TRACK, is looking at whether people with rare cancers can benefit from treatments chosen based on their tumor's genetic information. You would have special tests called FoundationOne CDx and FoundationOne Liquid CDx, which analyze your tumor and blood for genetic changes. A team of experts (Virtual Molecular Tumor Board) will then review your results and suggest treatments to your doctor. The study will track how many participants receive these recommended treatments and how long they live without their cancer getting worse. This study is for adults (18 and older) with a rare solid tumor or lymphoma. The current recruitment status is unclear, but the study plans to enroll 400 people.

Study design
This is an open-label, non-randomized study, meaning both you and your doctors will know what treatments are being considered. It aims to enroll 400 participants.
What's involved
You would need to provide signed consent and be willing to have blood draws and assessments throughout the study. You will undergo comprehensive genomic profiling of your tumor and blood.
Compensation
Not stated in the trial record.
Follow-up
The study will track outcomes like receiving matched treatment and progression-free survival for 2 years.

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NCT04504604

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Recruiting
NAAges 18+InterventionalDiagnostic
TargetCancer Foundation
~400 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:FoundationOne CDx and FoundationOne Liquid CDx

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
Measured over 2 years
+1 more outcome measured

Conditions

Rare Cancers
Cholangiocarcinoma
Cancer of Unknown Primary Site

Explore related trials

CholangiocarcinomaLymphomaMalignant Neoplasm of Unknown PrimaryRare CancersSolid Neoplasm

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Razelle Kurzrock, M.D. · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
  • Vivek Subbiah, M.D. · PRINCIPAL_INVESTIGATOR · Stanford University
  • Shumei Kato, M.D. · PRINCIPAL_INVESTIGATOR · University of California, San Diego
  • Mina Nikanjam, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Mary Oster
[email protected]
617-299-0389
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.2 years

    The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.

  • Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.2 years

    The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.