Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06102889

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastrocentrum, KarolinskaUniversity Hospital

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liquid Biopsy

Diagnostic Test

Taking blood samples (liquid biopsy) for multiple analysis in genomics, proteomics, and metabolomics

Primary outcomes

  1. Recurrence of pancreatic cancer

    Time frame: 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 outcomes

  1. Effect of standard-of-care (SOC) chemotherapy on biomarker(s)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

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

Registry information

Acronym: GUIDEMRD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.