The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study (NCT02520713) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
United States825 participantsStarted 2015-10
Plain-language summary
This research study is evaluating the use of specialized testing of solid tumors including sequencing. The process of performing these specialized tests is called tumor profiling. The tumor profiling may result in identifying changes in genes of the tumor that indicate that a particular therapy may have activity. This is called an individualized cancer therapy (iCat) recommendation. The results of the tumor profiling and, if applicable, the iCat recommendation will be returned.
Who can participate
Age range30 Years
SexALL
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Inclusion Criteria:
* Age -- Age ≤ 30 years at time of initial qualifying solid tumor diagnosis
* Diagnosis -- Histologic diagnosis of solid malignancy (excluding brain tumors and lymphoma) that meets at least one of the following criteria:
* Refractory, defined as tumor progression after initiation of standard first line therapy without having achieved a prior partial or complete remission OR Biopsy proven residual disease at the completion of planned standard initial front-line therapy.
* Recurrent, defined as tumor progression after achieving a prior partial or complete remission
* Newly diagnosed high risk disease, defined as having an expected event free survival of \< 50% at 2 years.
* Lacks definitive diagnosis or classical genomic findings after histologic review and standard molecular testing (rare tumor group).
* Examples include (eligibility not limited to these examples):
* Histology typically associated with a fusion in which fusion is not detected.
* Ewing-like sarcoma
* Undifferentiated sarcoma
* Inflammatory myofibroblastic tumor without ALK fusion
* Infantile fibrosarcoma without NTRK fusion
* Specimen Samples
* Sufficient tumor specimen available to meet the minimum requirements for profiling from diagnosis or progression / recurrence
\--- OR
* Surgery / biopsy planned as part of clinical care that is anticipated to yield sufficient material to meet the minimum requirements for profiling; OR
* Patient has already had molecular profiling…