Recruiting

TCF-001

Sponsor:

TargetCancer Foundation

Code:

NCT04504604

Conditions

Rare Cancers

Cholangiocarcinoma

Cancer of Unknown Primary Site

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FoundationOne CDx and FoundationOne Liquid CDx

Study Details

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.

Conditions

Rare Cancers

Cholangiocarcinoma

Cancer of Unknown Primary Site

Study ID

NCT04504604

Start date

Oct 1, 2020

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Cholangiocarcinoma

Eligible patients that present with Cholangiocarcinoma.

active comparator: Cancer of Unknown Primary (CUP)

Eligible patients with cancer of unknown primary site (CUP).

active comparator: Other remaining rare cancers (solid tumors & lymphomas)

Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).

Interventions

FoundationOne CDx and 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.

Primary outcome measure

  • Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. [ Time Frame: 2 years ]
  • Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Mary Oster

617-299-0389track@targetcancer.org

Locations

TargetCancer Foundation

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Mary Oster

617-299-0389track@targetcancerfoundation.org

Principal Investigator:

Shumei Kato, M.D

More Information

Sponsor

TargetCancer Foundation

Last update posted

May 26, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by TargetCancer Foundation on 2026-05-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.