The overall objective of this GUIDE.MRD consortium 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, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after
1. curative-intended surgery and 2. adjuvant chemotherapy.
FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project
Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
Age 18 years or older.
Scheduled for curative intent surgical resection.
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.
Patients with resected PDAC
Cohort
Prospective
Blood sample/Liquid Biopsy
Biological/VaccinectDNA analysis
3-year Disease-free survival (DFS)
Disease-free survival was defined as the time between the date of the baseline blood sampling/inclusion and the date of the first event among or recurrence or death from any cause.
Sensitivity (Se) of the ctDNA diagnostics
Sensitivity (Se) of the ctDNA diagnostics is calculated in subjects with a 3-year recurrence: Se = TP/(TP+FN) (a positive reference test)
Specificity (Sp) of the ctDNA diagnostics
Specificity (Sp) of the ctDNA diagnostics is calculated in subjects without a 3-year recurrence: Sp = TN/(TN+FP) (a negative reference test)
Positive predictive value of the ctDNA diagnostics
The predictive value of a positive test or positive predictive value (PPV): PPV = TP/(TP+FP).
Negative predictive value of the ctDNA diagnostics
The predictive value of a negative test or negative predictive value (NPV): NPV =TN/(TN+FN).
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