Clinical trial · Observational
The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
Multicenter Cohort Study To Evaluate Outcomes After Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults With Solid Tumors: The iCat2, GAIN Consortium Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic testing and GAIN report | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Genetic testing and GAIN report
- description
- All enrolled patients will submit specimens for sequencing and analysis.
- interventionNames
- Genetic: Genetic testing and GAIN report
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 18 months
- description
- In pediatric patients with recurrent or refractory solid tumors who undergo successful molecular profiling, a) to describe the overall survival of patients by treatment group (iCatM, iCatUM and UM); b) to identify demographic, clinical, and genomic factors associated with overall survival from the time of relapse/progression (OSr); and c)to store tumor material, derived cell lines / xenografts, and blood samples for general sample banking and potential future research.
Secondary outcomes (4)
- measure
- Identification of the patient, clinical, and medication access factors associated with a) having an iCat recommendation and b) with receipt of matched targeted therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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 \< 50 will be excluded.
* Life Expectancy -- Patients with anticipated life expectancy \< 3 months will be excluded.References
Publications (0)
Data not yet available