What this study is
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.
What's being tested
- FoundationOne CDx and FoundationOne Liquid CDx
Intervention · 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.
Study details
- Sponsor
- TargetCancer Foundation
- Conditions
- Rare Cancers · Cholangiocarcinoma · Cancer of Unknown Primary Site
- Enrolling
- 400 people
- Starts
- 2020-10-01
- Est. completion
- 2028-12
- Design
- Open-label, non-randomized, factorial
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openTargetCancer Foundation
Cambridge, Massachusetts, United States
- Mary Oster · Contact617-299-0389track@targetcancerfoundation.org
- Shumei Kato, M.D · Principal investigator
Recruiting
Study team
Sponsor
TargetCancer Foundation
Study ID TCF-001
Principal investigator
Razelle Kurzrock, M.D.
Medical College of Wisconsin
Principal investigator
Vivek Subbiah, M.D.
Stanford University
Principal investigator
Shumei Kato, M.D.
University of California, San Diego
Principal investigator
Mina Nikanjam, MD
University of California, San Diego
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.