Systematic Evaluation of Human Explant Model Systems Engineering

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04671654

Studienbeginn:
August 2020

Letztes Update:
21.12.2021

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
German Cancer Research Center

Studienleiter

Dirk Jaeger, Prof. Dr. med.
Study Chair
University Hospital Heidelberg

Kontakt

Azaz Ahmed, Dr. med.
Kontakt:
Phone: +49-6221-56-7229
E-Mail: Azaz.Ahmed@med.uni-heidelberg.de» Kontaktdaten anzeigen

Niels Halama, Dr. med.
Kontakt:
Phone: +49-6221-56-4801
E-Mail: Niels.Halama@nct-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

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

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