TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rare Cancers Cholangiocarcinoma Cancer of Unknown Primary Site

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cholangiocarcinoma

Eligible patients that present with Cholangiocarcinoma.

Group Type ACTIVE_COMPARATOR

FoundationOne CDx and FoundationOne Liquid CDx

Intervention Type DIAGNOSTIC_TEST

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.

Cancer of Unknown Primary (CUP)

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

Group Type ACTIVE_COMPARATOR

FoundationOne CDx and FoundationOne Liquid CDx

Intervention Type DIAGNOSTIC_TEST

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 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).

Group Type ACTIVE_COMPARATOR

FoundationOne CDx and FoundationOne Liquid CDx

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FoundationOne CDx FoundationOne Liquid CDx

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No