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

  • STATUS
    Recruiting
  • End date
    Oct 16, 2025
  • participants needed
    825
  • sponsor
    Dana-Farber Cancer Institute
Updated on 16 May 2022

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.

Description

Patients with extra-cranial (not in the brain) solid tumors that are either difficult to diagnose or more difficult to treat are eligible to participate in this study. All enrolled patients will have targeted sequencing of tumor performed. Sequencing results will be reviewed for clinically significant findings including determination of whether any mutations exist that suggest potential for activity of a targeted therapy (iCat recommendation). Results will be returned to the patient's oncologist and follow-up data will be collected.

In this prospective multi-center cohort study, the primary objective is to describe the outcomes of pediatric patients with advanced solid tumors according to whether or not they received of targeted therapy matched to an iCat recommendation. The primary clinical outcome of interest is the endpoint of overall survival (OS), with progression-free survival and response rate (RR) as key secondary clinical outcome measures. To address this hypothesis, 825 patients will enroll from an anticipated 11 participating institutions over 3 years.

Details
Condition Pediatric Solid Tumor
Treatment Genetic testing and GAIN report
Clinical Study IdentifierNCT02520713
SponsorDana-Farber Cancer Institute
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

No Therapy Planned
\-- Patients who have declined further anticancer therapy will be excluded
Performance Status
\-- Patients with Lansky (age < 16 years) or Karnofsky (age ≥16 years) score <
will be excluded
Life Expectancy -- Patients with anticipated life expectancy < 3 months will be excluded
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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