INFORM Registry

Recurrent tumours or tumours that have progressed under therapy with a diagnosis of ALL-HR, ALL post-SCT, AML, rhabdoid tumours, ependymoma, medulloblastoma, Ewing's sarcoma, high-grade glioma, high-risk neuroblastoma, non-Hodgkin's lymphoma, osteosarcoma and soft tissue sarcoma. Primary disease of a high-grade glioma (incl. DIPG), a specific soft tissue sarcoma or ETMR without a curative treatment option. In exceptional cases, ‘other’ paediatric refractory or progressive/relapsed entities, including rare tumour diseases, can be included in the registry after consultation with the INFORM Trial Office (and in the case of a rare tumour disease with the GPOH STEP Registry, in the case of nephroblastoma, hepatoblastoma, retinoblastoma, malignant endocrine tumours or germ cell tumours with the respective GPOH study group). The principle of the INFORM programme is to characterise tumour samples obtained from routine biopsies using state-of-the-art molecular genetic methods as precisely as possible today, regardless of the diagnosis, in patients with relapse or progression of the malignant disease for whom no established treatment concept is available. From such a ‘fingerprint’ of the tumour, a panel of experts (experienced paediatric oncologists, bioinformaticians, biologists, pharmacologists) will then classify the changes found for each individual patient according to clinical relevance. This molecular information should be available in less than 4 weeks. Within the framework of the registry, no therapy recommendations are made, only the molecular information - the treating physician has access to the biological information obtained on his patient and bears full responsibility as to whether and in what form he uses it for his therapy decision.

{ "short_title": "INFORM Registry", "data_mode": "900", "data_mode_number": "000002463", "official_title": "INFORM \u2013 INdividualized Therapy FOr Relapsed Malignancies in Childhood", "accrual_state": "running", "therapeutic_value": null, "therapieansatz_value": null, "therapieintervention_value": null, "therapielinie_value": null, "ctgov_number": null, "eudract_number": null, "general_contact_email": "Kik-dokuteam-hs65@ukdd.de", "general_contact_phone": "+49 351-4585035", "hauptpruefer_dd_name": "Dr. med. Claudia Zinke", "description_laie_de": "Rezidivierte oder unter Therapie progrediente Tumorerkrankungen mit der Diagnose ALL-HR, ALL Post-SCT, AML, Rhabdoide Tumoren, Ependymom, Medulloblastom, Ewing-Sarkom, hochgradiges Gliom, Hochrisiko-Neuroblastom, Non-Hodgkin Lymphom, Osteosarkom und Weichteilsarkom. Prim\u00e4rerkrankung eines hochgradigen Glioms (inkl. DIPG), einem spezifischen Weichteilsarkom oder ETMR ohne kurative Behandlungsoption. In Ausnahmef\u00e4llen k\u00f6nnen \u201eandere\u201c p\u00e4diatrische refrakt\u00e4re oder progressive/r\u00fcckf\u00e4llige Entit\u00e4ten, inklusive seltene Tumorerkrankungen nach R\u00fccksprache mit dem INFORM-Trial Office (und im Falle einer seltenen Tumorerkrankung mit dem GPOH STEP Register, im Falle von Nephroblastom, Hepatoblastom, Retinoblastom, malignen endokrinen Tumoren oder Keimzelltumoren mit der jeweiligen GPOH Studiengruppe) in das Register aufgenommen werden.\r\n\r\nDas Prinzip des INFORM-Programms ist, unabh\u00e4ngig von der Diagnose, bei Patienten mit R\u00fcckfall oder Progress der b\u00f6sartigen Erkrankung, f\u00fcr die kein etabliertes Behandlungskonzept mehr zur Verf\u00fcgung steht, durch Routinebiopsien gewonnene Tumorproben mit modernsten molekulargenetischen Methoden so genau wie heute m\u00f6glich zu charakterisieren. Aus einem solchen \"Fingerabdruck\" des Tumors werden dann von einem Expertengremium (erfahrene Kinderonkologen, Bioinformatiker, Biologen, Pharmakologen) f\u00fcr jeden einzelnen Patienten die gefundenen Ver\u00e4nderungen nach klinischer Relevanz klassifiziert. Diese molekulare Information soll in weniger als 4 Wochen vorliegen. Im Rahmen des Registers werden keine Therapieempfehlungen, sondern lediglich die molekularen Informationen weitergegeben \u2013 der behandelnde Arzt hat Zugriff auf die gewonnenen biologischen Informationen seines Patienten und tr\u00e4gt die volle Verantwortung, ob und in welcher Form er diese f\u00fcr seine Therapieentscheidung nutzt.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "Recurrent tumours or tumours that have progressed under therapy with a diagnosis of ALL-HR, ALL post-SCT, AML, rhabdoid tumours, ependymoma, medulloblastoma, Ewing's sarcoma, high-grade glioma, high-risk neuroblastoma, non-Hodgkin's lymphoma, osteosarcoma and soft tissue sarcoma. Primary disease of a high-grade glioma (incl. DIPG), a specific soft tissue sarcoma or ETMR without a curative treatment option. In exceptional cases, \u2018other\u2019 paediatric refractory or progressive/relapsed entities, including rare tumour diseases, can be included in the registry after consultation with the INFORM Trial Office (and in the case of a rare tumour disease with the GPOH STEP Registry, in the case of nephroblastoma, hepatoblastoma, retinoblastoma, malignant endocrine tumours or germ cell tumours with the respective GPOH study group).\r\n\r\nThe principle of the INFORM programme is to characterise tumour samples obtained from routine biopsies using state-of-the-art molecular genetic methods as precisely as possible today, regardless of the diagnosis, in patients with relapse or progression of the malignant disease for whom no established treatment concept is available. From such a \u2018fingerprint\u2019 of the tumour, a panel of experts (experienced paediatric oncologists, bioinformaticians, biologists, pharmacologists) will then classify the changes found for each individual patient according to clinical relevance. This molecular information should be available in less than 4 weeks. Within the framework of the registry, no therapy recommendations are made, only the molecular information - the treating physician has access to the biological information obtained on his patient and bears full responsibility as to whether and in what form he uses it for his therapy decision.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 14, "sub_cat_id": 66 }

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