RecruitingNot ApplicableNCT06666803

Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours (CancerProfile by FNB)

Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours


Sponsor

IHU Strasbourg

Enrollment

60 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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.

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Interventions

OTHERFNB sampling

A supplementary FNB will be performed during the EUS procedure. Sample will be processed to obtain organoids and assess their morphological, proliferative and genetics characteristics.

BIOLOGICALblood sampling

A blood withdrawal will be performed during the EUS procedure. Sample will be processed to assess organoids morphological, proliferative and genetics characteristics.


Locations(2)

Centre d'Endoscopie Digestive

Strasbourg, France

Department of hepato-gastroenterology

Strasbourg, France

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NCT06666803


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