TCF-001 TRACK (Target Rare Cancer Knowledge) Study

NCT04504604 | Recruiting FDA Device

• 1 other identifier: TCF-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (1)

• Comparison of Tumor Biomarker Profiling to Treatment Outcome.

  2 years

Study Arms (3)

Cholangiocarcinoma

ACTIVE COMPARATOR

Eligible patients that present with Cholangiocarcinoma.

Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx

Cancer of Unknown Primary (CUP)

ACTIVE COMPARATOR

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

Diagnostic Test: FoundationOne CDx and FoundationOne Liquid CDx

Other remaining rare cancers (solid tumors & lymphomas)

ACTIVE COMPARATOR

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

Interventions

FoundationOne CDx and FoundationOne Liquid CDx 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.

Also known as: FoundationOne CDx, FoundationOne Liquid CDx

Cancer of Unknown Primary (CUP); Cholangiocarcinoma; Other remaining rare cancers (solid tumors & lymphomas)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TargetCancer Foundation: lead
• Foundation Medicine: collaborator

Study Sites (1)

TargetCancer Foundation

Cambridge, Massachusetts, 02139, United States

RECRUITING

Related Links

• Study information

MeSH Terms

Conditions

Cholangiocarcinoma; Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Razelle Kurzrock, M.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Vivek Subbiah, M.D.

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

• Shumei Kato, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Oster

CONTACT

617-299-0389; track@targetcancerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)