The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study

Prior treatment

• No Therapy Planned
  • \-- Patients who have declined further anticancer therapy will be excluded.

Age

• Performance Status
  • \-- Patients with Lansky (age \< 16 years) or Karnofsky (age ≥16 years) score \< 50 will be excluded.

Other

• Life Expectancy -- Patients with anticipated life expectancy \< 3 months will be excluded.

• 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 and patient has not yet started matched targeted therapy based on the report .