INFORM Registry Study on Individualized Treatment for Patients with Recurrent Malignant Disease, with a Special Focus on Children and Adolescents

Cancer develops when cells multiply uncontrollably. Treatment aims to halt this uncontrolled growth and thereby contain the disease. However, through changes (mutations), cancer cells can develop mechanisms that make them resistant to therapies, allowing them to continue growing unchecked; these are referred to as treatment-resistant tumors. In such cases, additional imaging tests such as CT, MRI, or tissue analyses are performed to determine whether the cancer has changed and which therapy might be effective. Depending on the results, treatment is switched to other options, such as a different class of drugs or combination therapy. As long as a cure appears possible (curative treatment), the goal is to completely eliminate the cancer, whereas in cases of incurable diseases, the focus is on controlling the disease and maintaining quality of life (palliative treatment).

When standard therapies are no longer sufficient, modern approaches such as molecular genetic analyses can be used to determine the genetic changes in the tumor and thus identify targeted treatment options with drugs specifically designed to address them. However, these genetic tests are not yet part of routine care, as they are expensive, time-consuming, and not equally available to all patients.

The goal of the INFORM-REGISTER study is to gather as comprehensive information as possible through specialized genetic testing and, as a result, potentially propose new treatment approaches. To this end, tissue samples (biopsies)—which are collected as part of standard care—are analyzed using state-of-the-art methods to create a genetic “fingerprint” of each individual tumor. The identified tumor alterations are discussed for each individual patient in a panel of experts to determine whether they make individualized treatment possible—that is, whether suitable medications or ongoing studies are already available. Treating physicians are given access to this information and can use it to inform further treatment decisions. This study is purely a registry study designed to compile information; this means that no new treatments are being tested within the study, nor are any treatment recommendations being made.

Patients up to 40 years of age with previously treated, treatment-resistant, or advanced cancer are eligible to participate in the study. The initial diagnosis of the disease must have been made before the age of 21. Certain rare cancers, such as high-grade gliomas, may also be included in the study immediately after the initial diagnosis. There must be no standard treatment option remaining that could cure the patients.