Solid Tumor, AdultSEEDLINGNCT04671654
Systematic Evaluation of Human Explant Model Systems Engineering
An observational study of Solid Tumor, Adult, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
All current forms of therapy for tumor patients are essentially based on clinical, genomic or histopathological criteria for the choice of therapy. However, the change in the tissue during therapy is of particular importance for patients, both with regard to the development of resistance and the side effect profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with solid tumor diseases in a non-curative setting.
Who may be able to join
- Tissue material for Explant Model generation available or accessible
Who cannot join
- curatively resected/treated tumors
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg / NCT
Heidelberg, 69120
Niels Halama, PD Dr. med, +49 6221-56-7229, Niels.Halama@med.uni-heidelberg.de
Azaz Ahmed, Dr. med., +49-6221-56-7229, Azaz.Ahmed@med.uni-heidelberg.de
About this study
All current forms of therapy for tumor patients are essentially based on clinical, genomic or histopathological criteria for the choice of therapy. However, the change in the tissue during therapy is of particular importance for patients, both with regard to the development of resistance and the side effect profile. This applies in particular to immunotherapies and their use in advanced tumor diseases. Preliminary work on the fully human tumor explant model has shown that the use of human donor tissue in the context of a special bioreactor makes it possible to improve the possibilities of predicting and better understanding the mechanism of action of a therapeutic agent. Since there is a considerable need for personalized and thus improved therapy management in the field of oncology, the aim of this study is on the one hand to improve the decisive tissue parameters for the cultivation of human donated material and on the other hand to understand the basic reaction patterns of the tissue to therapies.
Read the 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.
- Conditions
- Solid Tumor, Adult
- Keywords
- cancer, metastases, immunotherapy, radiation, chemotherapy, targeted therapy
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Biopsy Specimen vs Tumor Explant Model Prediction
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
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Aug 2020
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Principal investigator, Niels Halama, University Hospital Heidelberg
- Investigators
- Dirk Jaeger, Prof. Dr. med., Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671654
- Sponsor's protocol ID
- U1111-1254-2831-S-507/2019
- Other IDs
- U1111-1254-2831
- Acronym
- SEEDLING
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Halama N, Zoernig I, Berthel A, Kahlert C, Klupp F, Suarez-Carmona M, Suetterlin T, Brand K, Krauss J, Lasitschka F, Lerchl T, Luckner-Minden C, Ulrich A, Koch M, Weitz J, Schneider M, Buechler MW, Zitvogel L, Herrmann T, Benner A, Kunz C, Luecke S, Springfeld C, Grabe N, Falk CS, Jaeger D. Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients. Cancer Cell. 2016 Apr 11;29(4):587-601. doi: 10.1016/j.ccell.2016.03.005.
PubMed 27070705
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Human Explant Model Systems Engineering
- ClinicalTrials.gov ID
- NCT04671654
- Acronym / sponsor ID
- SEEDLING / U1111-1254-2831-S-507/2019
- Conditions
- Solid Tumor, Adult
- Keywords
- cancer, metastases, immunotherapy, radiation, chemotherapy, targeted therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All current forms of therapy for tumor patients are essentially based on clinical, genomic or histopathological criteria for the choice of therapy. However, the change in the tissue during therapy is of particular importance for patients, both with regard to the development of resistance and the side effect profile. This applies in particular to immunotherapies and their use in advanced tumor diseases. Preliminary work on the fully human tumor explant model has shown that the use of human donor tissue in the context of a special bioreactor makes it possible to improve the possibilities of predicting and better understanding the mechanism of action of a therapeutic agent. Since there is a considerable need for personalized and thus improved therapy management in the field of oncology, the aim of this study is on the one hand to improve the decisive tissue parameters for the cultivation of human donated material and on the other hand to understand the basic reaction patterns of the tissue to therapies.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with solid tumor diseases in a non-curative setting.
Key inclusion criteria (1 listed)
- Tissue material for Explant Model generation available or accessible
Key exclusion criteria (1 listed)
- curatively resected/treated tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 27070705Halama N, Zoernig I, Berthel A, Kahlert C, Klupp F, Suarez-Carmona M, Suetterlin T, Brand K, Krauss J, Lasitschka F, Lerchl T, Luckner-Minden C, Ulrich A, Koch M, Weitz J, Schneider M, Buechler MW, Zitvogel L, Herrmann T, Benner A, Kunz C, Luecke S, Springfeld C, Grabe N, Falk CS, Jaeger D. Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients. Cancer Cell. 2016 Apr 11;29(4):587-601. doi: 10.1016/j.ccell.2016.03.005.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Jaeger, Prof. Dr. med. study chair
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azaz Ahmed, Dr. med. (+49-6221-56-7229, Azaz.Ahmed@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Biopsy Specimen vs Tumor Explant Model Prediction (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.