Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT07034703
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.
Study:
NCT07034703
Study Brief:
Protocol Section:
NCT07034703