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

Primary Purpose

Rare Cancers, Cholangiocarcinoma, Cancer of Unknown Primary Site

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FoundationOne CDx and FoundationOne Liquid CDx

About this trial

This is an interventional diagnostic trial for Rare Cancers focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TargetCancer FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Cholangiocarcinoma

Cancer of Unknown Primary (CUP)

Other remaining rare cancers (solid tumors & lymphomas)

Arm Description

Eligible patients that present with Cholangiocarcinoma.

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04504604

First Posted

August 5, 2020

Last Updated

October 21, 2022

Sponsor

TargetCancer Foundation

Collaborators

Foundation Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04504604

Brief Title

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Acronym

TRACK

Official Title

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TargetCancer Foundation

Collaborators

Foundation Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rare Cancers, Cholangiocarcinoma, Cancer of Unknown Primary Site

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cholangiocarcinoma

Arm Type

Active Comparator

Arm Description

Eligible patients that present with Cholangiocarcinoma.

Arm Title

Cancer of Unknown Primary (CUP)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Other remaining rare cancers (solid tumors & lymphomas)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

FoundationOne CDx and FoundationOne Liquid CDx

Other Intervention Name(s)

FoundationOne CDx, FoundationOne Liquid CDx

Intervention Description

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 Information:

Title

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

Description

Time Frame

2 years

Title

Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Comparison of Tumor Biomarker Profiling to Treatment Outcome.

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Oster

Phone

617-299-0389

mary@targetcancerfoundation.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Razelle Kurzrock, M.D.

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vivek Subbiah, M.D.

Organizational Affiliation

The University of Texas MD Anderson Cancer Center (MDACC)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shumei Kato, M.D.

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

TargetCancer Foundation

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Oster

Phone

617-299-0389

Mary@targetcancerfoundation.org

First Name & Middle Initial & Last Name & Degree

Shumei Kato, M.D

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.targetcancerfoundation.org/track

Description

Study information

Learn more about this trial

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

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