RecruitingNot ApplicableNCT04504604

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Sponsor

TargetCancer Foundation

Enrollment

400 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Rare Cancers Cancer of Unknown Primary Site

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria7

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.

Interventions

DIAGNOSTIC_TESTFoundationOne 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.