Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours (CancerProfile by FNB)
Recruiting · NCT06666803 · Interventional (participants receive a specific treatment) · Lead sponsor: IHU Strasbourg
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Pancreatic ductal adenocarcinoma (PDAC) has the poorest prognosis of all digestive cancers due to lack of early diagnosis and limited response to treatment. Patient-derived organoid technology has become a mainstay of precision oncology, enabling personalised functional characterisation of tumours (e.g. treatment evaluation and drug screening). Initial research carried out as part of the Cancer Profile project has produced the first organoids from resected PDAC parts. Only 15-20% of patients can benefit from surgical resection, which remains the only curative treatment. In contrast, most patients with PDAC undergo diagnostic fine-needle biopsies (FNB) using an echo-endoscopic procedure (EUS). The next step is therefore the reliable generation of organoids from limited quantities of biopsy material obtained by 'EUS-FNB'. The aim of the study presented here is to validate these organoids on the basis of the following characteristics: (i) morphological and proliferative characteristics, (ii) recapitulation of the genetic characteristics of the original tumour, (iii) expression of tumour markers.
Who can take part
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 it is running
2 locations listed.
- Centre d'Endoscopie Digestive - Strasbourg, France
- Department of hepato-gastroenterology - Strasbourg, France