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

NCT06102889 | Enrolling By Invitation DMC

• 1 other identifier: GUIDE.MRD-02-PDAC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 month - 24 months after surgical resection of the tumor

Interventions

liquid biopsy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Gastrocentrum, KarolinskaUniversity Hospital

Stockholm, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for circulating tumour DNA (ctDNA), exosomes, proteomics, metabolomics, and circulating tumour cells (CTC)

MeSH Terms

Interventions

Liquid Biopsy

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Claus Lindbjerg Andersen, MD

  Aarhus University Hospitsl

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology & Hepatology

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: May 2, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

SE (1)