Gastrocentrum, KarolinskaUniversity Hospital
Stockholm, 14186, Sweden
NCT Number: NCT06102889
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Stockholm, 14186, Sweden
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taking blood samples (liquid biopsy) for multiple analysis in genomics, proteomics, and metabolomics
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.
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.
Karolinska University Hospital
Other
Acronym: GUIDEMRD
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.
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