Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06666803

Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours

Led by IHU Strasbourg · Updated on 2026-04-16

60

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

I

IHU Strasbourg

Lead Sponsor

L

Luxembourg Institute of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pancreatic ductal adenocarcinoma (PDAC) is a digestive cancer with the poorest outlook due to late diagnosis and limited treatment response. This research focuses on creating and validating patient-derived organoids from biopsy samples to enable personalized tumor analysis. The study aims to confirm that these organoids reflect the original tumor's morphology, genetic features, and tumor marker expression, advancing personalized cancer care. The study involves patients undergoing an echo-endoscopic fine-needle biopsy (EUS-FNB) to collect pancreatic tumor samples. One to two biopsies will be used for regular diagnostic analysis, while an additional biopsy will be used to create organoids. This biopsy is split into three parts: one for organoid culture, one preserved for genetic comparison, and one analyzed using innovative imaging technology (Dynamic Full-field Optical Coherence Tomography). Blood samples will also be collected for genomic analysis. Participants will undergo standard EUS-FNB biopsy with an extra sample taken for research purposes. Researchers will evaluate organoid development over 8 weeks and assess their accuracy in replicating tumor features. Additional evaluations include protocol effectiveness over 3 months and imaging analysis on the first day. The study ensures careful monitoring of tumor characteristics and genetic profiles to support personalized treatment strategies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient over 18 years of age.
  • Undergoing echo-endoscopy with certainty or suspicion of fine needle biopsy (EUS-FNB).
  • Suspicion of pancreatic lesion.
  • Able to receive, understand information about the research protocol, and give consent.
  • Affiliated with the French social security system.
Not Eligible

You will not qualify if you...

  • Not scheduled for endoscopy with certainty or suspicion of fine needle biopsy (EUS-FNB).
  • Undergoing echo-endoscopy but at high risk that may prevent EUS-FNB.
  • Has degenerated Intraductal papillary mucinous neoplasm (IPMN).
  • Had acute pancreatitis within 4 weeks before EUS.
  • Pregnant or breastfeeding.
  • Under court protection.
  • Under guardianship or curatorship.
  • In a situation of social vulnerability.
  • Under legal protection or unable to express opposition.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day 1

Participants undergo an echo-endoscopy with fine needle biopsy (EUS-FNB) to obtain tissue samples and blood withdrawal for genomic and organoid analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 months

Participants' biopsied tumour samples are cultured to develop organoids. These organoids are analyzed for morphological, genetic, and proliferative characteristics over time.

No additional visits; analyses are conducted on collected samples

Trial Site Locations

Total: 2 locations

1

Centre d'Endoscopie Digestive

Strasbourg, France

Actively Recruiting

2

Department of hepato-gastroenterology

Strasbourg, France

Actively Recruiting

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Research Team

A

Armelle TAKEDA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Frequently Asked Questions

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