Personalised organoid profiling from biopsy for pancreatic cancer
Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours
This project will try to grow and test mini‑tumors (organoids) from echo‑endoscopic fine‑needle biopsies to help guide treatment for people with suspected pancreatic ductal adenocarcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Strasbourg and 1 other locations) |
| Trial ID | NCT06666803 on ClinicalTrials.gov |
What this trial studies
The protocol collects small tissue samples by echo‑endoscopic fine‑needle biopsy (EUS‑FNB) and blood samples to generate patient‑derived organoids (PDOs) from pancreatic lesions. These PDOs will be characterised for morphology, growth/proliferation, and molecular features and used for functional testing including drug sensitivity screens. The goal is to validate whether reliable organoids can be made from routine diagnostic biopsies rather than only from surgical resections. Successful generation and profiling could expand personalised testing to the majority of PDAC patients who are not surgical candidates.
Who should consider this trial
Good fit: Adults over 18 undergoing echo‑endoscopy with planned fine‑needle biopsy for a suspected pancreatic lesion who can give informed consent and are affiliated to the French social security system.
Not a fit: Patients unlikely to benefit include those who cannot safely undergo EUS‑FNB, those with recent acute pancreatitis, degenerated IPMN, pregnant or breast‑feeding individuals, legally protected adults who cannot consent, or anyone whose biopsy does not yield viable organoids.
Why it matters
Potential benefit: If successful, this could let clinicians test anti‑cancer drugs on a patient's own organoid to better tailor chemotherapy choices.
How similar studies have performed: Organoids from surgical PDAC specimens have recapitulated tumor histology and predicted drug responses, but generation of reliable organoids from routine EUS‑FNB biopsies has been reported only in a few cases and remains less well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient over 18 years of age. * Patient undergoing echo-endoscopy with certainty/suspicion of fine needle biopsy (EUS-FNB). * Suspicion of pancreatic lesion * Patient able to receive and understand information relating to the research protocol and to give consent. * Patient affiliated to the French social security system. Exclusion Criteria: * Patient not programmed for endoscopy with certainty/suspicion of fine needle biopsy (EUS-FNB). * Patient undergoing echo-endoscopy and presenting a high risk that may prevent EUS-FNB. * Patient with degenerated Intraductal papillary mucinous neoplasm (IPMN) * Patient with acute pancreatitis within 4 weeks prior to EUS * Pregnant or breast-feeding patient * Patient under court protection. * Patient under guardianship or curatorship. * Patient in a situation of social vulnerability. * Patient under legal protection or unable to express his/her opposition.
Where this trial is running
Strasbourg and 1 other locations
- Centre d'Endoscopie Digestive — Strasbourg, France (Recruiting)
- Department of hepato-gastroenterology — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Armelle TAKEDA
- Email: armelle.takeda@ihu-strasbourg.eu
- Phone: +33390413608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.