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

• Conditions: Pancreatic Adenocarcinoma

• Registration Number: NCT06102889
• Lead Sponsor: Karolinska University Hospital

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.

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 Timeline

• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-22
• Study First Posted: 2023-10-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Study Start: 2024-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of pancreatic cancer	1 month - 24 months after surgical resection of the tumor	Occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gastrocentrum, KarolinskaUniversity Hospital; 🇸🇪 Stockholm, Sweden