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

Pancreatic Adenocarcinoma Clinical Trial

— GUIDEMRD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06102889
• Other study ID #: GUIDE.MRD-02-PDAC
• Status: Enrolling by invitation
• Start date: May 2, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm, Residual
• Pancreatic Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
Sweden	Gastrocentrum, KarolinskaUniversity Hospital	Stockholm

Sponsors (7)

Lead Sponsor	Collaborator
Karolinska University Hospital	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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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