NCT04246203

Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery. Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
OTHER	Liquid Biopsy	17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.

Timeline

• Start date: 2021-12-12
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2020-01-29
• Last updated: 2025-03-11

Locations

6 sites across 1 country: Germany