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iCAT for Recurrent/Refractory/HR Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01853345
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Katherine Janeway, MD, Dana-Farber Cancer Institute

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.

Condition or disease
Pediatric Solid Tumor Sarcoma Neuroblastoma Wilms Tumor

Detailed Description:

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.

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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

Refractory/Recurrent/High Risk Solid Tumors

Primary Outcome Measures :
  1. Frequency of a cancer causing actionable alteration and individualized treatment recommendation. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood samples, tumor samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Study Population
Pediatric patients with recurrent, refractory or high risk solid tumors

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01853345

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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
Sponsors and Collaborators
Dana-Farber Cancer Institute
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Principal Investigator: Katherine Janeway, MD Dana-Farber Cancer Institute
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Katherine Janeway, MD, Principal Investigator, Dana-Farber Cancer Institute 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
Keywords provided by Katherine Janeway, MD, Dana-Farber Cancer Institute:
High Risk
Additional relevant MeSH terms:
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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