GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES

Study Overview

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.

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 project's electronic database and stored physically in a locked space.

Pancreatic Adenocarcinoma

DIAGNOSTIC_TEST: liquid biopsy

GUIDE.MRD-02-PDAC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-10-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-23
First Submitted that Met QC Criteria 2023-10-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-24
First Posted (ACTUAL) 2023-10-26	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Recurrence of pancreatic cancer	Occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.	1 month - 24 months after surgical resection of the tumor

Secondary Outcome Measures	Measure Description	Time Frame
Effect of standard-of-care (SOC) chemotherapy on biomarker(s)	Disappearance or re-occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.	1 month - 24 months after surgical resection of the tumor

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
Age 18 years or older.
Patient able to understand and sign written informed consent in Swedish.
Scheduled for curative intent surgical resection.

Hereditary pancreatic cancer.
Verified distant metastases.
Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Universitätsklinikum Hamburg-Eppendorf
Aarhus University Hospital
Centre Hospitalier Universitaire de Nice
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Medical University of Graz
Centre Hospitalier Régional Universitaire Montpellier

Investigators

STUDY_DIRECTOR: Claus Lindbjerg Andersen, MD, Aarhus University Hospitsl

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record