INFORM Registry

Author: Julia Dobke, erstellt am: 2014/11/03, Last modification: 2019/09/17

INFORM Registry INFORM – INdividualized Therapy FOr Relapsed Malignancies in Childhood
Disease Refractory/relapsed/progressive: ALL-HR, ALL post-SCT, AML, CWS / rhabdomyosarcoma, ependymoma and medulloblastoma, ewing sarcoma, high grade glioma (incl. DIPG), neuroblastoma, NHL osteosarcoma, rhabdoid tumors, “other”
Type Registry
Problem / Objectives

Although current treatment of childhood malignancies results in overall cure rates in the order of 75% with modern multi-modal treatment protocols, relapses from high risk disease remains a tremendous clinical problem. Only a small proportion of patients with relapses (about 10%) can be cured. This medical need will be addressed with the INFORM project „INdividualized Therapy FOr Relapsed Malignancies in Childhood“.

Primary objectives

  • Establishment of logistics for personalized treatment
  • Establishment of a comprehensive database
  • Collection of data on individual genomic, epigenomic, transcriptomic characteristics of high risk refractory/relapsed/progressive pediatric malignancies
  • Evaluation of collected data
Therapy / Study arms

The concept of the INFORM-program is to biologically characterize tumor samples (collected through routine standard of care biopsies) for all pediatric patients with relapsed or refractory high risk disease for which no further standard of care therapy is available, independently of histological diagnosis. State-of-the art next-generation sequencing technologies will be applied to get a “fingerprint” of each individual tumor. An expert panel of experienced pediatric oncologists, bioinformaticians, biologists and pharmacologists classifies and weighs the aberrations/targets found for each single patient according to clinical relevance. These molecular targets shall be available in less than 4 weeks and will be entered in the central database. No therapy recommendation will be given within this registry study. The treating physician has access to the molecular information/targets of his patients and carries the full responsibility as to whether and in which way he uses these data for his therapy decision making.

Inclusion Criteria

Inclusion criteria for the registry population are relapsed/progressive or refractory diagnoses of ALL-HR, ALL Post-SCT, AML, rhabdoid tumor, ependymoma, medulloblastoma, ewingsarcoma, high grade glioma, high risk neuroblastoma, non-hodgkin lymphoma, osteosarcoma and rhabdomyosarcoma in case of no established curative treatment.
The patients are 1 to 40 years old and were treated according to a protocol of the Society for Pediatric Oncology und Hematology (GPOH) as their first-line protocol, except in case of specific primary rhabdomyosarcoma indications. Exceptionally, “other” pediatric refractory or progressive/relapsed entities may be registered following consultation with the INFORM trial office before enrollment.

Recruitment 260 patients in Germany and additional international patients within 2 years
Status Start: 19/01/2015
Principal Investigator Prof. Dr. med. Olaf Witt

NCT Studienzentrale

Ruth Witt, M.Sc. MA / Cornelis van Tilburg, M.D., Ph.D
Im Neuenheimer Feld 350
69120 Heidelberg
Tel: 06221 56 7294 / 06221 56 7255
Fax: 06221 56 5863


Pathologisches Institut
Dr. Petra Fiesel
Abteilung Neuropathologie/INFORM
Sekretariat Prof. Dr. A. von Deimling
Zimmer 04.032
Im Neuenheimer Feld 224
69120 Heidelberg
Tel: 06221-56-4650
Fax: 06221-56-4566

Koordinierende Investoren

Coordinating Investigators

Prof. Dr. med. Olaf Witt Universität Heidelberg, Hopp-Kindertumorzentrum am NCT Heidelberg (KiTZ) Zentrum für Kinder- und Jugendmedizin & Klinische Kooperationseinheit Päd.Onkologie der Uniklinik Heidelberg und dem DKFZ Im Neuenheimer Feld 430 69120 Heidelberg Telefon +49-6221 42 3570 Fax +49 6221 42 3277 Hopp-Kindertumorzentrum Heidelberg

Leiter der Abteilung Pädiatrische Neuroonkologie, DKFZ

Dr. med. Stefan Pfister (Heidelberg)

Direktorin der Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie, Charité – Universitätsmedizin Berlin

Prof. Dr. med. Angelika Eggert (Berlin)

Participants GPOH hospitals
Weitere Informationen status in October 2018