Rare CancersTRACKNCT04504604
TCF-001 TRACK (Target Rare Cancer Knowledge) Study
A study testing FoundationOne CDx and FoundationOne Liquid CDx in people with Rare Cancers and Cholangiocarcinoma, run by TargetCancer Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rare Cancers, Cholangiocarcinoma, Cancer of Unknown Primary Site
- What is being tested?
- FoundationOne CDx and FoundationOne Liquid CDx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TargetCancer Foundation
Cambridge, Massachusetts, 02139
Mary Oster, 617-299-0389, track@targetcancerfoundation.org
Shumei Kato, M.D
About this study
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.
Read the detailed description
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. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study.
Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study.
The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.
- Being tested
- FoundationOne CDx and FoundationOne Liquid CDx
- Keywords
- genomics, precision medicine, molecular tumor board, remote participation, targeted therapy, patient reported outcomes, understudied diseases, comprehensive genomic profiling, virtual, next generation sequencing, liquid biopsies, tumor biopsies, cell-free DNA, biomarker testing, solid tumors
- Medical subject headings
- Cholangiocarcinoma, Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOne CDx and FoundationOne Liquid CDxDiagnostic test
Also called FoundationOne CDx, FoundationOne Liquid CDx
Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Cholangiocarcinoma | Active comparator | Eligible patients that present with Cholangiocarcinoma. Receives: Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx |
| Cancer of Unknown Primary (CUP) | Active comparator | Eligible patients with cancer of unknown primary site (CUP). Receives: Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx |
| Other remaining rare cancers (solid tumors & lymphomas) | Active comparator | Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States). Receives: Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
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.
Measured: 2 years
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.
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.
Measured: 2 years
Secondary outcomes (1)
Comparison of Tumor Biomarker Profiling to Treatment Outcome.
Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2020
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TargetCancer Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Medicine
- Responsible party
- Sponsor
- Investigators
- Razelle Kurzrock, M.D., Principal investigator, Medical College of WisconsinVivek Subbiah, M.D., Principal investigator, Stanford UniversityShumei Kato, M.D., Principal investigator, University of California, San DiegoMina Nikanjam, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504604
- Sponsor's protocol ID
- TCF-001
- Acronym
- TRACK
- Status last verified
- May 2026
- First submitted
- 5 Aug 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No