Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours (CancerProfile by FNB)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIHU Strasbourg
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
FNB sampling
Other interventionA supplementary FNB will be performed during the EUS procedure. Sample will be processed to obtain organoids and assess their morphological, proliferative and genetics characteristics.
blood sampling
Biological/VaccineA blood withdrawal will be performed during the EUS procedure. Sample will be processed to assess organoids morphological, proliferative and genetics characteristics.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: FNB and blood sample analysisExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
8 weeksSecondary outcomes
1
Evaluation of the protocol for culturing organoids derived from PDAC EUS-FNB biopsies.
Evaluation of the mutations found in the organoid from the EUS-FNB biopsies compared to those in the original sample preserved in liquid nitrogen (qualitative criterion).
Time frame
3 months2
Evaluation of the protocol for culturing organoids derived from PDAC EUS-FNB biopsies.
Evaluation of the mutations observed in the cancerous tissue (snap-frozen sample) compared to those observed in the blood sample from the same patient.
Time frame
3 months3
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)
Number of EUS-FNB tumour samples confirmed by D-FF-OCT, compared with the total number of samples taken.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IHU Strasbourg
Lead sponsor
Luxembourg Institute of Health
Collaborator
Source ClinicalTrials.gov