Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102889
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2023-10-22
Brief Title:
GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
GUIDEMRD
Brief Summary:
The overall objective of this study 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 we want to determine the association between disease-free survival DFS and ctDNA detection status after 1 curative-intended surgery and 2 adjuvant chemotherapy
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence
Specifically we want to determine the association between disease-free survival DFS and ctDNA detection status after 1 curative-intended surgery and 2 adjuvant chemotherapy
Detailed Description:
The study will prospectively enroll patients who undergo potentially curative surgery for PDAC The intervention is repeated blood sampling at pre-defined time points
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
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