JOURNAL ONKOLOGIE – STUDIE

Establishment of 2D and 3D Primary Cell Cultures From Gastric and Gastroesophageal Junction Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale

Noch nicht rekrutierend

NCT-Nummer:
NCT05541874

Studienbeginn:
Dezember 2023

Letztes Update:
10.03.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Studienleiter

Claudia Spies, MD, Prof
Study Director
Charite University, Berlin, Germany

Kontakt

Claudia Spies, MD, Prof.
Kontakt:
Phone: +49 30 450 55 11 02
E-Mail: claudia.spies@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
13353 Berlin
(Berlin)
Germany» Google-Maps
Ansprechpartner:
Claudia Spies, MD, Prof.
Phone: +49 30 450 55 11 02
E-Mail: claudia.spies@charite.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Gastric cancer is among the leading causes of cancer-related death worldwide. Surgery or

radiation monotherapy are applicable as treatment for localized tumors, however, the majority

of patients are diagnosed in an advanced disease state requiring systemic therapy

Chemotherapies are non-specific, affecting healthy tissues, and the overall response rate in

gastric tumors is limited. As such, there is a large unmet medical need for targeted

therapies against gastric tumors. Recent advances in the field of onco-immunology unraveled

the mechanisms of immune response against cancer, leading to the development of

immunotherapeutic strategies such as: immune check point inhibitors (ICIs), and advanced

therapy medicinal products (ATMPs), e.g. chimeric antigen receptor (CAR) T cells. ICIs and

CAR T cell therapy in particular have evolved as novel therapeutic cornerstones against

hematological disease, but their efficacy against solid tumors remains poor. Accordingly, a

minority of gastric cancer patients show durable responses to immunotherapies and there is

currently no cellular immunotherapy available for gastric cancer. Further, gastric tumors are

heterogeneous due to genomic changes, cellular composition, and the microenvironment,

conferring a very variable response to immunotherapies. Thus, a personalized approach is

needed, in order to understand individual resistance mechanisms and to predict which patients

are most suitable for which therapy.

To address this need, test systems resembling patient-specific tumor biology are required.

Cell lines lack 3D context and lose their genetic fidelity through passaging. Patient-derived

murine xenograft models provide 3D environment and multi-organ context, but the

xeno-environment hampers reliability and translatability. The investigators envision

patient-derived tumor organoids as a superior model, as they are 3D self-organizing

structures which reflect the tumor complexity. In addition, they have the potential to serve

as patient avatars and preclinical models to predict the efficacy of therapies.

In this study, the investigators will establish patient-derived organoids and to study

individual tumor biology and as testing platforms for (immune-) therapies. The investigators

further investigate the individual biology of the patients tumors and healthy tissues to not

only understand the heterogeneous mechanisms of gastric cancer but also the heterogeneous

mechanisms of healthy gastric tissue in the fields of infectiology and immunology.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with gastric or gastroesophageal junction cancer

Exclusion Criteria:

- Age < 18 years

Studien-Rationale

Primary outcome:

1. Establishing primary cell cultures from gastric and gastroesophageal junction cancer. (Time Frame - 06/2018-05/2021):
With this study, want to establish an efficient protocol for the generation of primary cell cultures from gastric and gastroesophageal junction cancer. Primary outcome is the success rate of primary cell culture establishment.

Secondary outcome:

1. Investigating mechanisms of disease in the individual patient. (Time Frame - 06/2018-05/2021):
With this study, we want to generate primary cell cultures that represent the patients individual tumor. We want to use the primary cell cultures to model individual resistance mechanisms to therapies, immunotherapies like CAR T cells in particular.

Quelle: ClinicalTrials.gov

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