The iCat2, GAIN Consortium Study
DFCI Protocol ID: 15-169
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.
Dana-Farber Cancer Institute, Children's Hospital Boston
Katherine Janeway, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, firstname.lastname@example.org
- Age -- Age â‰¤ 30 years at time of initial qualifying solid tumor 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
- Recurrent, defined as tumor progression after achieving a prior partial or
- Newly diagnosed high risk disease, defined as having an expected event free
survival of < 50% at 2 years.
- 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 demonstrating a potentially
targetable variant in a laboratory certified to generate a clinical report, but
the patient has not yet started therapy matched to the variant AND sufficient
tumor specimen is available to meet the minimum requirement for profiling from
the same procedure and tissue from which the prior testing was performed.
- No Therapy Planned
-- Patients who have declined further anticancer therapy will be excluded.
- Performance Status
-- Patients with Lansky (age < 16 years) or Karnofsky (age â‰¥16 years) score < 50 will
- Life Expectancy -- Patients with anticipated life expectancy < 3 months will be