Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478056
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-12
Brief Title:
Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
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:
VEINOPAN
Brief Summary:
This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood portal venous blood collected intraoperatively as well as its detection in peritoneal fluid
Detailed Description:
Pancreatic adenocarcinoma is the 6th most common cancer in France and is expected to be the 2nd leading cause of cancer mortality in Europe by 2030 Its overall 5-year survival for all stages combined is estimated at 7-8
Surgery is the only potentially curative treatment for pancreatic adenocarcinoma PA although only 10-20 of patients present with resectable disease The oncological results of surgery alone are disappointing median overall survival OS of 15-20 months and 5-year OS of 8-15 due to the high frequency of recurrence For this reason surgery must be integrated into a comprehensive treatment sequence also known as multimodal therapy
Significant progress has been observed over the past 5 years with a marked increase in median OS in recent clinical trials and an intensification of perioperative chemotherapy CT protocols
Liquid biopsy and circulating biomarkers show promise for improving the multidisciplinary approach to treatment of pancreatic adenocarcinoma
Circulating tumor DNA ctDNA is the most extensively studied marker in blood liquid biopsies and can provide insight into the molecular profile and individual characteristics of the tumor This could pave the way for the identification of new therapeutic targets and markers of tumor response to complement diagnosis and provide improved stratified treatment Similarly the measurement of tcDNA in peritoneal fluid could provide a better understanding of individual tumour characteristics and the risk of peritoneal metastasis
It is important to assess whether portal venous ctDNA is likely to provide distinct information from peripheral venous ctDNA if the two ctDNAs are highly correlated then it seems unlikely that one can provide complementary information to the other
In addition our work would evaluate the prognostic impact of the detection of circulating tumor DNA in portal venous blood collected intraoperatively as well as its detection in peritoneal fluid
Surgery is the only potentially curative treatment for pancreatic adenocarcinoma PA although only 10-20 of patients present with resectable disease The oncological results of surgery alone are disappointing median overall survival OS of 15-20 months and 5-year OS of 8-15 due to the high frequency of recurrence For this reason surgery must be integrated into a comprehensive treatment sequence also known as multimodal therapy
Significant progress has been observed over the past 5 years with a marked increase in median OS in recent clinical trials and an intensification of perioperative chemotherapy CT protocols
Liquid biopsy and circulating biomarkers show promise for improving the multidisciplinary approach to treatment of pancreatic adenocarcinoma
Circulating tumor DNA ctDNA is the most extensively studied marker in blood liquid biopsies and can provide insight into the molecular profile and individual characteristics of the tumor This could pave the way for the identification of new therapeutic targets and markers of tumor response to complement diagnosis and provide improved stratified treatment Similarly the measurement of tcDNA in peritoneal fluid could provide a better understanding of individual tumour characteristics and the risk of peritoneal metastasis
It is important to assess whether portal venous ctDNA is likely to provide distinct information from peripheral venous ctDNA if the two ctDNAs are highly correlated then it seems unlikely that one can provide complementary information to the other
In addition our work would evaluate the prognostic impact of the detection of circulating tumor DNA in portal venous blood collected intraoperatively as well as its detection in peritoneal fluid
Study Oversight
Has Oversight DMC:
None
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?:
None