Establishment of Pancreas Cancer and Cancer-associated Fibroblast Using EUS-guided Biopsy Samples
Simultaneous Establishment of Pancreas Cancer and Cancer-associated Fibroblast Using EUS-guided Biopsy Samples
1 other identifier
interventional
50
1 country
1
Brief Summary
Organoid has emerged as the novel platform for preclinical anticancer drug testing in pancreatic ductal adenocarcinoma (PDA). However, most organoid models are not reconstituted with a tumor microenvironment. This study aimed to simultaneously establish PDA organoids and cancer-associated fibroblasts (CAFs) using endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedOctober 10, 2022
October 1, 2022
3.7 years
October 5, 2022
October 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
simultaneous establishment of pancreatic ductal adenocarcinoma organoids and cancer-associated fibroblasts
The proportion of patients with successful establishment of pancreatic ductal adenocarcinoma organoids and cancer-associated fibroblasts
From the EUS-FNB procedure til 2 weeks after EUS-FNB
Study Arms (1)
Pancreatic ductal adenocarcinoma organoids and cancer-associated fibroblasts establishment group
EXPERIMENTALIf a sufficient visible core was obtained on macroscopic inspection, the tissue materials from the following one needle pass were placed into the transfer medium for organoid generation. Using a tiny portion (about 20%) of the FNB sample, we isolated CAFs u
Interventions
Pancreatic masses were sampled using a 22-gauge FNB needle. If a sufficient visible core was obtained on macroscopic inspection, the tissue materials from the following one needle pass were placed into the transfer medium for organoid generation. Using a tiny portion (about 20%) of the FNB sample, we isolated CAFs
Eligibility Criteria
You may qualify if:
- solid pancreatic mass lesion presumed PDA on cross-sectional imaging, regardless of tumor resectability
You may not qualify if:
- inability to provide informed consent, or coagulopathy (international normalized ratio \>1.5, platelet count \<50,000 per mcL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou University Hospital
Suwon, Gyeong Gi Do, 443-721, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Min Jae Yang, MD, PhD
Ajou University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 7, 2022
Study Start
July 1, 2020
Primary Completion
February 28, 2024
Study Completion
February 28, 2025
Last Updated
October 10, 2022
Record last verified: 2022-10