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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Diagnostic test: liquid biopsy

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Gastrocentrum, KarolinskaUniversity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with histologically verified pancreatic adenocarcinoma (from surgically removed tumour tissue = ground truth) regardless of their ability to receive SOC adjuvant chemotherapy or not (observation only - due to pre-existing medical conditions), regardless of type of chemotherapy.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Medical University of Graz; Aarhus University Hospital; Centre Hospitalier Universitaire de Nice; Universitätsklinikum Hamburg-Eppendorf; Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III; Centre Hospitalier Régional Universitaire Montpellier
• Investigators: Study Director: Claus Lindbjerg Andersen, MD, Aarhus University Hospitsl

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Liquid biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm, Residual
• Other Study ID Numbers: GUIDE.MRD-02-PDAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After completion of the study, the SAB and study group to decide whether to share the results on a group level, i.e. anonymously

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No