Clinical trial NCT06102889: GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
Official title: GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic Adenocarcinoma
Keywords: Liquid biopsy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
name: Aarhus University Hospital
name: Centre Hospitalier Universitaire de Nice
name: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Medical University of Graz
name: Centre Hospitalier Régional Universitaire Montpellier
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of pancreatic cancer
timeFrame: 1 month - 24 months after surgical resection of the tumor
Secondary outcomes:
measure: Effect of standard-of-care (SOC) chemotherapy on biomarker(s)
timeFrame: 1 month - 24 months after surgical resection of the tumor
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Gastrocentrum, KarolinskaUniversity Hospital
Study officials:
affiliation: Aarhus University Hospitsl
name: Claus Lindbjerg Andersen, MD
role: STUDY_DIRECTOR
References: