NCT06666803

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2025Feb 2027

First Submitted

Initial submission to the registry

October 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

October 23, 2024

Last Update Submit

April 13, 2026

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

PDACEUSFNBPDOorganoidOCT

Outcome Measures

Primary Outcomes (1)

  • Organoid culture from PDAC EUS-FNB biopsy

    Qualitative assessment in the obtention of organoids. The main objective will be validated when a culture of functional organoids is generated.

    8 weeks

Secondary Outcomes (3)

  • Evaluation of the protocol for culturing organoids derived from PDAC EUS-FNB biopsies.

    3 months

  • Evaluation of the protocol for culturing organoids derived from PDAC EUS-FNB biopsies.

    3 months

  • Assessment of the overall accuracy of characterising PDAC EUS-FNB samples by optical slicing based on dynamic full-field optical coherence tomography (D-FF-OCT)

    Day 1

Study Arms (1)

FNB and blood sample analysis

EXPERIMENTAL
Other: FNB samplingBiological: blood sampling

Interventions

FNB samplingOTHER

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.

FNB and blood sample analysis
blood samplingBIOLOGICAL

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

FNB and blood sample analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'Endoscopie Digestive

Strasbourg, France

RECRUITING

Department of hepato-gastroenterology

Strasbourg, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Armelle TAKEDA

CONTACT

+33390413608armelle.takeda@ihu-strasbourg.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 31, 2024

Study Start

January 27, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)