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Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids
Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics.
Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology.
3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreas Cancer | Procedure: FNA, FNB | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids Generated From Matched Fine Needle Aspirations (FNA) and Fine Needle Biopsies (FNB) |
| Actual Study Start Date : | December 1, 2018 |
| Estimated Primary Completion Date : | August 1, 2021 |
| Estimated Study Completion Date : | August 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: FNA, FNB |
Procedure: FNA, FNB
Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy
|
- Growth rate [ Time Frame: 4 days ]Organoid growth will be determined using bi-weekly measurements by phase-contrast microscopy calculating the total organoid area as well as individual organoid size. In addition, growth rates will be determined using the cell glow assay (Promega) over a time-course of 4 days. Furthermore, the mean passaging time will be calculated after 5 passages.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with indication for EUS-guided FNA or FNB of a suspected pancreatic malignancy
Exclusion Criteria:
- < 18 years
- patients unable to give consent
| Contact: Christoph Schlag, MD | +49 89 4140 9357 | christoph.schlag@mri.tum.de | |
| Contact: Maximilian Reichert, MD | +49 89 4140 9454 | maximilian.reichert@tum.de |
| Germany | |
| 2nd Medical Department, Klinikum rechts der Isar | Recruiting |
| Munich, Germany, 81675 | |
| Contact: Christoph Schlag, MD +49 89 4140 9357 christoph.schlag@mri.tum.de | |
| Sub-Investigator: Johannes R Wiessner, MD | |
| Principal Investigator: Maximilian Reichert, MD | |
| Principal Investigator: Christoph Schlag, MD | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 17, 2019 | ||||||||
| First Posted Date ICMJE | June 19, 2019 | ||||||||
| Last Update Posted Date | June 19, 2019 | ||||||||
| Actual Study Start Date ICMJE | December 1, 2018 | ||||||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Growth rate [ Time Frame: 4 days ] Organoid growth will be determined using bi-weekly measurements by phase-contrast microscopy calculating the total organoid area as well as individual organoid size. In addition, growth rates will be determined using the cell glow assay (Promega) over a time-course of 4 days. Furthermore, the mean passaging time will be calculated after 5 passages.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids | ||||||||
| Official Title ICMJE | Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids Generated From Matched Fine Needle Aspirations (FNA) and Fine Needle Biopsies (FNB) | ||||||||
| Brief Summary |
Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics. Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology. 3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||||||
| Condition ICMJE | Pancreas Cancer | ||||||||
| Intervention ICMJE | Procedure: FNA, FNB
Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy
|
||||||||
| Study Arms ICMJE | Experimental: FNA, FNB
Intervention: Procedure: FNA, FNB
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 1, 2022 | ||||||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03990675 | ||||||||
| Other Study ID Numbers ICMJE | Pancreatic cancer organoids | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Technische Universität München | ||||||||
| Study Sponsor ICMJE | Technische Universität München | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Technische Universität München | ||||||||
| Verification Date | June 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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