Opposite II: REDESIGN
https://www.nct-dresden.de/en/trials/900-000002243
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Opposite II: REDESIGN
Section
NCT
Category
Gastrointestinal tumors
Subcategory
Esophageal and Gastric Cancer
Trial Type
Other clinical trials
Description for experts
By taking blood and tissue samples, tumor cells can be transferred into cell culture models (organoids). Using these organoid models, the response to various therapies as well as changes in the genetic material and cell composition can be analyzed under laboratory conditions. This means that the tumor cells and the genetic material (genes) of the tumor of the esophagus/stomach are examined using laboratory methods in order to enable a more individually effective therapy in the future. The goal of this study is to define alternative therapeutic options when organoid models do not respond to standard therapy for gastric cancer. The current clinical standard is that locally advanced, operable tumors are first treated with drug therapy (chemotherapy, possibly with targeted therapy or antibody therapy) to reduce the size of the tumor, followed by surgical removal of the tumor.
Another aspect of the REDESIGN study is to survey the patients, to determine the understanding of the role of organoid models in future precision oncology.
Description for laymen
JSON Data
{
"short_title": "Opposite II: REDESIGN",
"data_mode": "900",
"data_mode_number": "000002243",
"official_title": "Entwicklung von Therapieentscheidungen anhand von Magenkarzinomorganoiden",
"accrual_state": "running",
"therapeutic_value": "nonTherapeutic",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": null,
"eudract_number": null,
"general_contact_email": "studienzentrum-vtg@ukdd.de",
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. Daniel Stange",
"description_laie_de": "Durch Entnahme von Blut- und Gewebeproben k\u00f6nnen Tumorzellen in geeignete Zellkultur-Modelle (sog. Organoiden) \u00fcberf\u00fchrt werden. Anhand dieser Organoid-Modelle k\u00f6nnen unter Laborbedingungen das Ansprechen auf verschiedenen Therapien sowie Ver\u00e4nderungen im Erbgut und der Zellzusammensetzung analysiert werden. Das hei\u00dft, dass die Tumorzellen und die Erbsubstanz (Gene) des Tumors der Speiser\u00f6hre/des Magens mit Labormethoden untersucht werden, um zuk\u00fcnftig ggf. eine individuell effektivere Therapie zu erm\u00f6glichen. Ziel dieser wissenschaftlichen Untersuchung ist es, alternative Therapieoptionen zu definieren, wenn die Organoid-Modelle nicht auf die Standardtherapie beim Magenkarzinom ansprechen. Der bisherige klinische Standard sieht vor, dass bei lokal fortgeschrittenen, operablen Tumoren zun\u00e4chst eine medikament\u00f6se Therapie (Chemotherapie, ggf. mit zielgerichteter Therapie oder Antik\u00f6rpertherapie) zur Verkleinerung des Tumors durchgef\u00fchrt wird, gefolgt von der operativen Entfernung des Tumors. \r\nEin weiterer Aspekt der REDESIGN Studie ist die Befragung von Patient*innen, um ihr Verst\u00e4ndnis von der Rolle von Organoid-Modellen in der zuk\u00fcnftigen Pr\u00e4zisionsonkologie zu ermitteln.",
"description_laie_en": null,
"description_expert_de": null,
"description_expert_en": "By taking blood and tissue samples, tumor cells can be transferred into cell culture models (organoids). Using these organoid models, the response to various therapies as well as changes in the genetic material and cell composition can be analyzed under laboratory conditions. This means that the tumor cells and the genetic material (genes) of the tumor of the esophagus/stomach are examined using laboratory methods in order to enable a more individually effective therapy in the future. The goal of this study is to define alternative therapeutic options when organoid models do not respond to standard therapy for gastric cancer. The current clinical standard is that locally advanced, operable tumors are first treated with drug therapy (chemotherapy, possibly with targeted therapy or antibody therapy) to reduce the size of the tumor, followed by surgical removal of the tumor. \r\nAnother aspect of the REDESIGN study is to survey the patients, to determine the understanding of the role of organoid models in future precision oncology.",
"rechtsgrundlage_value": "BO",
"phase_amg_value": null,
"main_cat_id": 2,
"sub_cat_id": 5
}