iCAT for Recurrent/Refractory/HR Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Katherine Janeway, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01853345
First received: April 25, 2013
Last updated: January 2, 2014
Last verified: December 2013

April 25, 2013
January 2, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
Frequency of a cancer causing actionable alteration and individualized treatment recommendation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01853345 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
iCAT for Recurrent/Refractory/HR Solid Tumors
Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
99 Years
Retention:   Samples With DNA
Description:

Blood samples, tumor samples

Non-Probability Sample

Pediatric patients with recurrent, refractory or high risk solid tumors

  • Pediatric Solid Tumor
  • Sarcoma
  • Neuroblastoma
  • Wilms Tumor
Not Provided
Refractory/Recurrent/High Risk Solid Tumors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
Both
up to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01853345
11-406
No
Katherine Janeway, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Katherine Janeway, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP