JOURNAL ONKOLOGIE – STUDIE
SEEDLING Systematic Evaluation of Human Explant Model Systems Engineering
Rekrutierend
NCT-Nummer:
NCT04671654
Studienbeginn:
August 2020
Letztes Update:
17.12.2020
Wirkstoff:
-
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital Heidelberg
Collaborator:
German Cancer Research Center
Studienleiter
Study Chair
University Hospital Heidelberg
Kontakt
Kontakt:
Phone: +49-6221-56-7229
E-Mail: Azaz.Ahmed@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
University of Heidelberg / NCT
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Niels Halama, PD Dr. med
Phone: +49 6221-56-7229
E-Mail: Niels.Halama@med.uni-heidelberg.de
Azaz Ahmed, Dr. med.
Phone: +49-6221-56-7229
E-Mail: Azaz.Ahmed@med.uni-heidelberg.de» Ansprechpartner anzeigen
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Niels Halama, PD Dr. med
Phone: +49 6221-56-7229
E-Mail: Niels.Halama@med.uni-heidelberg.de
Azaz Ahmed, Dr. med.
Phone: +49-6221-56-7229
E-Mail: Azaz.Ahmed@med.uni-heidelberg.de» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:Personalized therapy is still one of the great goals of oncology. In view of the success of
checkpoint inhibitor therapies in selected solid tumors, the question remains why other tumor
diseases do not respond in the same way to the therapy. However, this is not only limited to
immunotherapies. In principle, the understanding of the dynamic changes in a patient's tissue
has so far been very limited, both for predicting a therapy success and with regard to the
mechanistic understanding of how a therapy works. Model systems for diseases are often animal
models that reproduce the complexity of a multi-organ system, but show significant
differences to humans at the tissue level and therefore have only little informative value.
Cell culture experiments, on the other hand, have only little informative value with regard
to the overall behavior of a tissue or even an organ or the disease situation. "Naturalistic"
co-culture in the Petri dish (such as with organoid systems) does not allow any sensible
transferable insights, even if complex cell compositions of fibroblasts, endothelium or
immune cells are used. In contrast, there is another problem for in vivo tumor models: either
there is a lack of flexibility with regard to the structural context or the species-specific
system properties do not allow any conclusions to be drawn about the situation in humans.
This is a massive limitation, especially for translational studies. The Tumor Explant Model
System developed by us allows the structural integrity of the tissue context to be maintained
in the context of obtaining a biopsy or removing a resection. The tissue sample obtained in
this way is kept in equilibrium via a bioreactor and can thus be used for tests or is
preserved in its context of the tissue. It is also possible in the sense of a personalized
diagnosis and therapy to take into account the individual bandwidth of the composition of the
tumor microenvironment. This approach has already been validated in a prospective study and
the transferability of the results from the explant models to humans has been proven. In this
situation, the systematic construction of explant models for other tumor entities and the use
of these models for therapy development and for better understanding of pathoregulation in
tissues. In addition to the tissue samples donated by the study participants, blood cells can
also be used for testing the tissue.hand to understand the basic reaction patterns of the
tissue to therapies.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Tissue material for Explant Model generation available or accessible
Exclusion Criteria:
- curatively resected/treated tumors
Studien-Rationale
Primary outcome:1. Tissue Biopsy Specimen vs Tumor Explant Model Prediction (Time Frame - up to 24 weeks):
Comparison of serial biopsy measurements to Explant Model measurements in the context of individual Patient variability, Serial biopsy timepoints can vary between 1 day up to 24 weeks
Quelle: ClinicalTrials.gov
