iCAT for Recurrent/Refractory/HR Solid Tumors
Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors
1 other identifier
observational
101
1 country
5
Brief Summary
In this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. This is called tumor profiling. A panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. If there is, the experts will determine if there is a targeted drug available that could counteract this alteration. If there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. The results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedFebruary 10, 2015
February 1, 2015
2.1 years
April 25, 2013
February 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of a cancer causing actionable alteration and individualized treatment recommendation.
2 years
Study Arms (1)
Refractory/Recurrent/High Risk Solid Tumors
Eligibility Criteria
Pediatric patients with recurrent, refractory or high risk solid tumors
You may qualify if:
- Diagnosis of recurrent, refractory of high risk pediatric solid tumor (excluding brain tumor)
- Histologic proof of malignancy at the time of diagnosis or recurrence
- Sufficient tumor specimen available for profiling from diagnosis or recurrence, or surgery/biopsy planned for clinical care
You may not qualify if:
- Brain tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California, San Francisco
San Francisco, California, 94143, United States
Children's National Medical center
Washington D.C., District of Columbia, 20010, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Columbia University
New York, New York, 10032, United States
Related Publications (1)
Harris MH, DuBois SG, Glade Bender JL, Kim A, Crompton BD, Parker E, Dumont IP, Hong AL, Guo D, Church A, Stegmaier K, Roberts CWM, Shusterman S, London WB, MacConaill LE, Lindeman NI, Diller L, Rodriguez-Galindo C, Janeway KA. Multicenter Feasibility Study of Tumor Molecular Profiling to Inform Therapeutic Decisions in Advanced Pediatric Solid Tumors: The Individualized Cancer Therapy (iCat) Study. JAMA Oncol. 2016 May 1;2(5):608-615. doi: 10.1001/jamaoncol.2015.5689.
PMID: 26822149DERIVED
Biospecimen
Blood samples, tumor samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Janeway, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 99 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2013
First Posted
May 15, 2013
Study Start
August 1, 2012
Primary Completion
September 1, 2014
Last Updated
February 10, 2015
Record last verified: 2015-02