RecruitingNot ApplicableNCT05788744

Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

Implementing Non-invasive Circulating Tumor DNA and Circular DNA Analysis in Patients With Localized Pancreatic Cancer to Optimize the Pre- and Postoperative Treatment: Predicting Recurrence and Survival and Changing Prognosis Over Time


Sponsor

Copenhagen University Hospital at Herlev

Enrollment

700 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate if plasma ctDNA and eccDNA before resection for suspicion of pancreatic ductal adenocarcinoma (PDAC) can predict early recurrence and overall survival, and to investigate if plasma ctDNA combined with CT scan and endoscopic ultrasound surveillance increases the median overall survival compared with standard-of-care surveillance.


Eligibility

Inclusion Criteria5

  • Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy.
  • Sub-study 2: .
  • PDAC tumor stage I-III
  • Has received intended curative resection (R0/R1) of PDAC
  • No signs of local recurrence or metastatic disease at a CT scan 4 months after the operation

Exclusion Criteria2

  • Other cancers (excluding skin cancer other than melanoma) later than 3 years before inclusion
  • Patients who are unlikely to comply with the protocol, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

Interventions

DIAGNOSTIC_TESTctDNA

ctDNA guided surveillance


Locations(5)

Aalborg Universitetshospital

Aalborg, Denmark

Aarhus Universitetshospital

Aarhus, Denmark

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Copenhagen University Hospital - Herlev and Gentofte

Herlev, Denmark

Odense Universitetshospital

Odense, Denmark

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NCT05788744


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