iCAT for Recurrent/Refractory/HR Solid Tumors
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ClinicalTrials.gov Identifier: NCT01853345 |
Recruitment Status :
Completed
First Posted : May 15, 2013
Last Update Posted : February 10, 2015
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Condition or disease |
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Pediatric Solid Tumor Sarcoma Neuroblastoma Wilms Tumor |
Some cancer-causing gene alterations (such as mutations or copy number alterations) are common or occur repeatedly in different types of cancers. For some of these alterations there are drugs, called targeted drugs that specifically counteract the alteration. In certain cancer types, these targeted drugs are very effective at fighting the cancer.
A tumor specimen that has been obtained previously or is planned to be obtained as part of clinical care will be used to perform tumor profiling. Additional procedures to obtain tumor will not be performed. An expert panel will review the results of the tumor profiling tests and determine whether a cancer-causing alteration is present and whether an individualized treatment recommendation can be made. If consent to sharing of the tumor profiling results and individualized treatment recommendation is provided then a study physician will discuss the profiling results and the individualized treatment recommendation with the primary oncologist. In addition, the primary oncologist will receive a letter detailing the tumor profiling results and the individualized treatment recommendation.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 101 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 99 Years |
Official Title: | Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | September 2014 |

Group/Cohort |
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Refractory/Recurrent/High Risk Solid Tumors |
- Frequency of a cancer causing actionable alteration and individualized treatment recommendation. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Brain tumors

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853345
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, District of Columbia | |
Children's National Medical center | |
Washington, District of Columbia, United States, 20010 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 |
Principal Investigator: | Katherine Janeway, MD | Dana-Farber Cancer Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Katherine Janeway, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT01853345 |
Other Study ID Numbers: |
11-406 |
First Posted: | May 15, 2013 Key Record Dates |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
Refractory Recurrent High Risk |
Neoplasms Neuroblastoma Wilms Tumor Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms, Complex and Mixed Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Kidney Diseases Urologic Diseases Genetic Diseases, Inborn |