TCF-001 TRACK (Target Rare Cancer Knowledge) Study (NCT04504604) | Clinical Trial Compass
RecruitingNot Applicable
TCF-001 TRACK (Target Rare Cancer Knowledge) Study
United States400 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
Timeframe: 2 years
2
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.