Target Rare Cancer Knowledge

Brief Title

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Official Title

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

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.
    

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 Type

Interventional

Primary Outcome

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

Secondary Outcome

 Comparison of Tumor Biomarker Profiling to Treatment Outcome.

Condition

Rare Cancers

Intervention

FoundationOne CDx and FoundationOne Liquid CDx

Study Arms / Comparison Groups

 Cholangiocarcinoma

Description:  Eligible patients that present with Cholangiocarcinoma.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

400

Start Date

October 1, 2020

Completion Date

December 2023

Primary Completion Date

September 2023

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Razelle Kurzrock, M.D., 617-299-0389, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04504604

Organization ID

TCF-001

Responsible Party

Sponsor

Study Sponsor

TargetCancer Foundation

Collaborators

 Foundation Medicine

Study Sponsor

Razelle Kurzrock, M.D., Principal Investigator, Medical College of Wisconsin

Verification Date

October 2022