Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer (PROJECTION)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Cancer
• Intervention / Treatment: Other: Liquid Biopsy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Benedikt Westphalen, MD; Phone Number: 75250 0049894400; Email: cwestpha@med.lmu.de
• Study Contact Backup: Name: Bernhard W. Renz, MD; Phone Number: 0049894400; Email: Bernhard.Renz@med.uni-muenchen.de

Study Locations

• Germany
  • Berlin, Germany
    • Not yet recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Uwe Pelzer, MD
  • Cologne, Germany
    • Not yet recruiting
    • Uniklinik Köln
    • Contact: Dirk Waldschmidt, MD
  • Hamburg, Germany
    • Not yet recruiting
    • Universitatsklinikum Hamburg-Eppendorf
    • Contact: Marianne Sinn, MD
  • Munich, Germany, 80333
    • Not yet recruiting
    • Technische Universität München
    • Contact: Michael Quante, MD
  • Ulm, Germany
    • Not yet recruiting
    • Universitätsklinikum Ulm
    • Contact: Thomas Seufferlein, MD
  • Bavaria
    • Munich, Bavaria, Germany, 80799
      • Recruiting
      • Ludwig Maximilians University Munich
      • Contact: Benedikt Westphalen, MD; Phone Number: 75250 +49894400; Email: cwestpha@med.lmu.de
      • Contact: Laura E. Fischer, MD; Phone Number: 73126 +49894400; Email: Laura.Fischer@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic mass, suspicious of pancreatic cancer and deemed resectable will be prospectively enrolled in this observational study.

Description

Inclusion Criteria:

1. Adult patients ≥ 18 years of age
2. Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
3. Patient deemed medically fit for adjuvant chemotherapy by the investigator
4. Patient's legal capacity to consent to study participation
5. Signed and dated informed consent to participate in the study

Exclusion Criteria:

1. Non-resectable disease as determined by a local tumor board
2. Metastatic pancreatic disease
3. Previous neoadjuvant chemotherapy
4. Previous neoadjuvant radiotherapy
5. Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
6. Malignant disease other than PDAC within previous year (exception: patients with adequately treated and completely resected basal cell or squamous cell skin cancer; in situ cervical, breast or prostate cancer within previous year may be included)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Patients are allocated to group A according to preoperative presence of detectable ctDNA.	Other: Liquid Biopsy; 17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
Group B; Patients are allocated to group B according to preoperative absence of detectable ctDNA.	Other: Liquid Biopsy; 17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Comparison of disease-free survival (DFS) of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B)	Follow up will be 36 months after surgery.

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: Benedikt Westphalen, LMU Munich

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ML40429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No