Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-31 @ 7:10 AM
Study NCT ID:
NCT07034703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort of Patients Treated Using Neoadjuvant Modified FOLFIRINOX 6 Cycles for Potentially Resectable Pancreatic Duct Adenocarcinoma, Candidate for Participation in the PANACHE02 Clinical Trial
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
Prospective Cohort of Patients Treated Using Neoadjuvant Modified FOLFIRINOX 6 Cycles for Potentially Resectable Pancreatic Duct Adenocarcinoma, Candidate for Participation in the PANACHE02 Clinical Trial PANACHE02-SC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANACHE02-SC
Brief Summary:
The aim of our study is to build up biological, radiological and tissue collections so as to identify, at the time of diagnosis of pancreatic adenocarcinoma, multifactorial factors and/or biomarkers (tissue, plasma, radiomic) predictive of the success of the complete therapeutic sequence.
So we can distinguish 3 biological collections here :
* Collection for ctDNA assay on STRECK tubes
* Collection on PAXgene tubes
* Tissus collection
Considering the biology collection for ctDNA assay : blood samples will be taken on specific tubes before the start of neoadjuvant chemotherapy (C1), Before C2 and after C4 of neoadjuvant chemotherapy. For ctDN assay, 2x 10ml STRECK tubes will be taken at each point for each patient.
At the end of the study, aliquots will be sent to INSERM unit U1245 to be analyzed
Considering the biology collection on PAXgene tubes : 2,5 ml blood samples will be taken in PAXgene blood RNA tube before C1 for each patient
Considering tissue collection: pre-chemotherapy biopsies and surgical specimens will be preserved after resection. Tissue sample will be collected and preserved in the tumor bank of Rouen university hospital,
By collecting data for all screened patients (complete sequence in PANACHE02, NT failure (progression), randomization failure after surgery) at diagnosis (clinicobiological data, pre-NT biopsies, blood samples and imaging data) we first aim to refine patient selection for NT benefit with a multivariable signature approach and to identify biomarkers (blood, imaging) monitoring during the neoadjuvant phase that could be predictive of early detection for NT treatment failure.
We therefore believe that the constitution of such cohort is critical to address numerous unmet needs.
So we can distinguish 3 biological collections here :
* Collection for ctDNA assay on STRECK tubes
* Collection on PAXgene tubes
* Tissus collection
Considering the biology collection for ctDNA assay : blood samples will be taken on specific tubes before the start of neoadjuvant chemotherapy (C1), Before C2 and after C4 of neoadjuvant chemotherapy. For ctDN assay, 2x 10ml STRECK tubes will be taken at each point for each patient.
At the end of the study, aliquots will be sent to INSERM unit U1245 to be analyzed
Considering the biology collection on PAXgene tubes : 2,5 ml blood samples will be taken in PAXgene blood RNA tube before C1 for each patient
Considering tissue collection: pre-chemotherapy biopsies and surgical specimens will be preserved after resection. Tissue sample will be collected and preserved in the tumor bank of Rouen university hospital,
By collecting data for all screened patients (complete sequence in PANACHE02, NT failure (progression), randomization failure after surgery) at diagnosis (clinicobiological data, pre-NT biopsies, blood samples and imaging data) we first aim to refine patient selection for NT benefit with a multivariable signature approach and to identify biomarkers (blood, imaging) monitoring during the neoadjuvant phase that could be predictive of early detection for NT treatment failure.
We therefore believe that the constitution of such cohort is critical to address numerous unmet needs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: