Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287749
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-08
Brief Title:
French Assessment of MRD by Liquid Biopsies in PDAC Patients FRENCHMRDPDAC
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
French Assessment of Minimal Residual Disease by Liquid Biopsies in Pancreatic Ductal Adenocarcinoma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The overall objective of this GUIDEMRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence and applicable in clinical practice
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence
Specifically the investigators want to determine the association between disease-free survival DFS and ctDNA detection status after
1 curative-intended surgery and
2 adjuvant chemotherapy
FRENCHMRDPDAC is the French study of the european GUIDEMRD project
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence
Specifically the investigators want to determine the association between disease-free survival DFS and ctDNA detection status after
1 curative-intended surgery and
2 adjuvant chemotherapy
FRENCHMRDPDAC is the French study of the european GUIDEMRD project
Detailed Description:
PDAC is the most common subtype of pancreatic cancer The main pillars of non-metastatic PDAC clinical management are i surgery and ii neoadjuvant treatment including chemotherapy which can be followed by external radiotherapy in case of borderlinelocally advanced tumors
Adjuvant chemotherapy is standard-of-care and is given to most patients that tolerate it after the extensive surgical procedure The sequence of perioperative chemotherapy before after both is currently a matter of debate
Despite extensive surgical resection and chemotherapy most patients relapse and median overall survival in the group of patients that is treated with surgery and modern chemotherapy regimens is below 24 months
Throughout the body DNA is released from cells into the circulation This DNA is collectively referred to as cell-free DNA cfDNA In a patient with a solid cancer such as PDAC a fraction of the cfDNA found in the blood originates from tumor cells and is termed circulating tumor DNA ctDNA
At present a multitude of different ctDNA tests are available and a common standard is lacking This study is part of the large EU-funded GUIDEMRD project that aims to develop international reference standards for ctDNA diagnostics and use the best standardized tests in clinically meaningful scenarios including postsurgery follow-up of patients with PDAC colorectal cancer and lung cancer
Detailed Description
The FRENCHMRDPDAC study will prospectively enroll patients in France who undergo potentially curative surgery for PDAC The intervention is repeated blood sampling at pre-defined time points
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-ofrecurrence
Specifically the investigators want to determine the association between 3-year disease-free survival DFS and ctDNA detection status after
1 curative-intended surgery and
2 adjuvant chemotherapy
Secondary objectives Secondary objective 1 S1 To technically assess compare and rank existing commercial ctDNA diagnostics after intended curative PDAC treatment upfront surgery or neoadjuvant treatment followed by surgery - postoperative chemotherapy to identify the best method at each time point with no impact on diagnosis or treatment of patients enrolled in the study
Secondary objective 2 S2 To assess the effect of standard-of-care adjuvant chemotherapy on the level of ctDNA Especially for patients with ctDNA detected after surgery the investigators will measure and compare the ctDNA levels in plasma samples drawn before and after adjuvant chemotherapy Furthermore the change in ctDNA level will be correlated to the oncological outcomes time to clinical recurrence disease-free survival and overall survival
Secondary objective 3 S3 To investigate if time to Molecular recurrence determined using serial ctDNA analyses in longitudinally collected plasma samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging
Secondary objective 4 S4 To investigate the correlation between ctDNA analysis results and findings on CT scans ctDNA analysis will be restricted to blood sampling times that are coinciding with standard-of-care CT scans If ctDNA analysis can predict the outcome of the CT scan the potential is that ctDNA analysis in the future can guide when to perform CT scans
Secondary objective 5 S5 To investigate the prognostic power of ctDNA at the time point of indeterminate CT scans
Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board MDT The screening will be done based on the electronic health record in the electronic journal at present for example Take Care The National Health Record may be accessed for some patients to complete the record
Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below Eligible patients are approached in person or initially by phone after they have been informed about the diagnosis and the planned surgery Patients are given written and oral information about the project by a trained research nurse or by an involved physician Informed consent will be obtained before the beginning of any study-related procedures
The signed and dated consent forms are scanned into the projects electronic database and stored physically in a locked space
Adjuvant chemotherapy is standard-of-care and is given to most patients that tolerate it after the extensive surgical procedure The sequence of perioperative chemotherapy before after both is currently a matter of debate
Despite extensive surgical resection and chemotherapy most patients relapse and median overall survival in the group of patients that is treated with surgery and modern chemotherapy regimens is below 24 months
Throughout the body DNA is released from cells into the circulation This DNA is collectively referred to as cell-free DNA cfDNA In a patient with a solid cancer such as PDAC a fraction of the cfDNA found in the blood originates from tumor cells and is termed circulating tumor DNA ctDNA
At present a multitude of different ctDNA tests are available and a common standard is lacking This study is part of the large EU-funded GUIDEMRD project that aims to develop international reference standards for ctDNA diagnostics and use the best standardized tests in clinically meaningful scenarios including postsurgery follow-up of patients with PDAC colorectal cancer and lung cancer
Detailed Description
The FRENCHMRDPDAC study will prospectively enroll patients in France who undergo potentially curative surgery for PDAC The intervention is repeated blood sampling at pre-defined time points
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-ofrecurrence
Specifically the investigators want to determine the association between 3-year disease-free survival DFS and ctDNA detection status after
1 curative-intended surgery and
2 adjuvant chemotherapy
Secondary objectives Secondary objective 1 S1 To technically assess compare and rank existing commercial ctDNA diagnostics after intended curative PDAC treatment upfront surgery or neoadjuvant treatment followed by surgery - postoperative chemotherapy to identify the best method at each time point with no impact on diagnosis or treatment of patients enrolled in the study
Secondary objective 2 S2 To assess the effect of standard-of-care adjuvant chemotherapy on the level of ctDNA Especially for patients with ctDNA detected after surgery the investigators will measure and compare the ctDNA levels in plasma samples drawn before and after adjuvant chemotherapy Furthermore the change in ctDNA level will be correlated to the oncological outcomes time to clinical recurrence disease-free survival and overall survival
Secondary objective 3 S3 To investigate if time to Molecular recurrence determined using serial ctDNA analyses in longitudinally collected plasma samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging
Secondary objective 4 S4 To investigate the correlation between ctDNA analysis results and findings on CT scans ctDNA analysis will be restricted to blood sampling times that are coinciding with standard-of-care CT scans If ctDNA analysis can predict the outcome of the CT scan the potential is that ctDNA analysis in the future can guide when to perform CT scans
Secondary objective 5 S5 To investigate the prognostic power of ctDNA at the time point of indeterminate CT scans
Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board MDT The screening will be done based on the electronic health record in the electronic journal at present for example Take Care The National Health Record may be accessed for some patients to complete the record
Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below Eligible patients are approached in person or initially by phone after they have been informed about the diagnosis and the planned surgery Patients are given written and oral information about the project by a trained research nurse or by an involved physician Informed consent will be obtained before the beginning of any study-related procedures
The signed and dated consent forms are scanned into the projects electronic database and stored physically in a locked space
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