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Trial Title:
Establishment of 2D and 3D Primary Cell Cultures From Gastric and Gastroesophageal Junction Cancer
NCT ID:
NCT05541874
Condition:
Gastric and Gastroesophageal Junction Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Summary:
In this study, the investigators will establish primary cell cultures from surgically
resected gastric and gastroesophageal junction cancer specimen that were collected
between 06/2018 and 05/2021.
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.
Criteria for eligibility:
Study pop:
Patients with gastric or gastroesophageal junction cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients with gastric or gastroesophageal junction cancer
Exclusion Criteria:
- Age < 18 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Contact:
Last name:
Claudia Spies, MD, Prof.
Phone:
+49 30 450 55 11 02
Email:
claudia.spies@charite.de
Investigator:
Last name:
Claudia Spies, MD, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Lukas Ehlen, MD
Email:
Sub-Investigator
Start date:
December 2023
Completion date:
May 11, 2026
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541874
