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 range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.