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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCF-001 TRACK (Target Rare Cancer Knowledge) Study
- ClinicalTrials.gov ID
- NCT04504604
- Acronym / sponsor ID
- TRACK / TCF-001
- Keywords
- genomics, precision medicine, molecular tumor board, remote participation, targeted therapy, patient reported outcomes, understudied diseases, comprehensive genomic profiling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- TargetCancer FoundationUniversity, hospital or other
- Collaborators
- Foundation Medicine
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholangiocarcinoma | Active comparator | Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDxEligible patients that present with Cholangiocarcinoma. |
| Cancer of Unknown Primary (CUP) | Active comparator | Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDxEligible patients with cancer of unknown primary site (CUP). |
| Other remaining rare cancers (solid tumors & lymphomas) | Active comparator | Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDxEligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoundationOne CDx and FoundationOne Liquid CDxAlso: FoundationOne CDx, FoundationOne Liquid CDxEligible 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. | Diagnostic test | Cancer of Unknown Primary (CUP), Cholangiocarcinoma, Other remaining rare cancers (solid tumors & lymphomas) |
Primary outcome
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Comparison of Tumor Biomarker Profiling to Treatment Outcome.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Oster (617-299-0389, track@targetcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.