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TCF-001 TRACK (Target Rare Cancer Knowledge) Study (TRACK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504604
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : October 24, 2022
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
TargetCancer Foundation

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.

Condition or disease Intervention/treatment Phase
Rare Cancers Cholangiocarcinoma Cancer of Unknown Primary Site Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: TCF-001 TRACK (Target Rare Cancer Knowledge) Study
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cholangiocarcinoma
Eligible patients that present with Cholangiocarcinoma.
Diagnostic Test: 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.
Other Names:
  • FoundationOne CDx
  • FoundationOne Liquid CDx

Active Comparator: Cancer of Unknown Primary (CUP)
Eligible patients with cancer of unknown primary site (CUP).
Diagnostic Test: 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.
Other Names:
  • FoundationOne CDx
  • FoundationOne Liquid CDx

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).
Diagnostic Test: 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.
Other Names:
  • FoundationOne CDx
  • FoundationOne Liquid CDx




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Comparison of Tumor Biomarker Profiling to Treatment Outcome. [ Time Frame: 2 years ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504604


Contacts
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Contact: Mary Oster 617-299-0389 mary@targetcancerfoundation.org

Locations
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United States, Massachusetts
TargetCancer Foundation Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Mary Oster    617-299-0389    Mary@targetcancerfoundation.org   
Principal Investigator: Shumei Kato, M.D         
Sponsors and Collaborators
TargetCancer Foundation
Foundation Medicine
Investigators
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Principal Investigator: Razelle Kurzrock, M.D. Medical College of Wisconsin
Principal Investigator: Vivek Subbiah, M.D. The University of Texas MD Anderson Cancer Center (MDACC)
Principal Investigator: Shumei Kato, M.D. University of California, San Diego
Additional Information:
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Responsible Party: TargetCancer Foundation
ClinicalTrials.gov Identifier: NCT04504604    
Other Study ID Numbers: TCF-001
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by TargetCancer Foundation:
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
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms, Unknown Primary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes