TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Launched by TARGETCANCER FOUNDATION · Aug 5, 2020

Keywords

ClinConnect Summary

The TCF-001 TRACK Study is looking at whether patients with rare cancers, such as cholangiocarcinoma (bile duct cancer) or cancers with an unknown primary site, can benefit from personalized treatments based on their genetic information. This study is open to adults aged 18 and older who have a rare tumor and are willing to provide blood and tissue samples for testing. Participants will need to sign a consent form and may have had a genetic test done previously, but it’s not required to join the study.

If you’re considering participating, you should know that the study is currently recruiting patients across multiple centers in the United States. Participants will undergo assessments and blood draws throughout the study. It’s important that you can read, write, and communicate in English and are in good health to follow the study procedures. If you meet the eligibility criteria, you could help researchers learn more about how tailored treatments might work for people with rare cancers.

Gender

ALL

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.