Who can enter
All children, adolescents and young adults with all types of kidney tumors
Goal
The goal of the scientific research belonging to the UMBRELLA protocol is, to make more children and young adults with kidney tumors better with as few side effects of the treatments as possible. To do this, we are doing research on the DNA in the tumor cells and on other properties of the tumor cell. In this way, we hope to be able to tell more quickly in the future which tumor a person has and how he or she will respond to treatment. We also hope this research will allow as many countries as possible to work in the same way.
Background
Most kidney tumors (75-80%) in children are Wilms tumors, also called nephroblastomas. The remaining 20-25% are some other type of kidney tumor. There is no certainty about the type of tumor until tissue testing is done. That is, the tumor, or a piece of it, has been viewed under the microscope. But radiological and clinical characteristics make it unnecessary to do a biopsy in most cases.
The standard treatment for a kidney tumor usually consists of chemotherapy (cytostatics) as initial treatment, followed by surgery and then usually chemotherapy and in some cases radiotherapy (radiation). Treatment after surgery depends on the tumor type and the expansion of the tumor in the body.
The UMBRELLA protocol provides internationally standardized diagnostic and treatment advice for children and young adults with kidney tumors and is now used in 30 countries in Europe, Asia and South America. The UMBRELLA protocol was created by experts in the treatment of kidney cancer in children and young adults: the International Society of Paediatric Oncology (SIOP) Renal Tumour Study Group (RTSG). This group has been in existence for more than 50 years, and the knowledge to craft protocols was obtained from 9 clinical trials and many published studies in more than 10,000 children with renal tumors anonymously collected in the international SIOP-RTSGG database.
UMBRELLA scientific research
One component of the UMBRELLA protocol consists of scientific research. This is integrated into the protocol and permission to use anonymized clinical and molecular data is requested.
If a child is participating in the scientific study, we will take additional blood and urine samples at specific times before and during treatment. These withdrawals are combined with regular care activities as much as possible. The blood draws are done via PAC/central line as much as possible, so that the child does not have to be given additional punctures.
After each surgery, whenever possible, we preserve pieces of the removed tumor tissue and removed surrounding healthy kidney tissue. We do this to examine the DNA in the cells from the tumor and the leftover normal kidney tissue. In doing so, we aim to answer the question of whether biological characteristics of the tumor can predict the outcomes of the child, so that in the future patients can receive even better treatment.
In addition, in most patients, DNA from healthy blood cells of the child and of the biological parents is examined to determine whether there is a genetic predisposition that explains why the child developed cancer. For this purpose, blood (1 tube) is taken from parents and child. DNA that is stored will only be examined after parents and child have been informed about this by the geneticist (clinical geneticist) and have given permission for this. Practically all children with a kidney tumor are referred to a clinical geneticist.