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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
Sponsored by
TargetCancer Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

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

First Posted
August 5, 2020
Last Updated
October 21, 2022
Sponsor
TargetCancer Foundation
Collaborators
Foundation Medicine
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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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

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
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.
Time Frame
2 years
Title
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comparison of Tumor Biomarker Profiling to Treatment Outcome.
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Email
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
Email
Mary@targetcancerfoundation.org
First Name & Middle Initial & Last Name & Degree
Shumei Kato, M.D

12. IPD Sharing Statement

Plan to Share IPD
No
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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