Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

NCT04246203 | Active Not Recruiting

• 1 other identifier: ML40429
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group A

Patients are allocated to group A according to preoperative presence of detectable ctDNA.

Other: Liquid Biopsy

Group B

Patients are allocated to group B according to preoperative absence of detectable ctDNA.

Other: Liquid Biopsy

Interventions

Liquid Biopsy OTHER

17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-resectable disease as determined by a local tumor board
• Metastatic pancreatic disease
• Previous neoadjuvant chemotherapy
• Previous neoadjuvant radiotherapy
• Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Hoffmann-La Roche: collaborator

Study Sites (6)

Ludwig Maximilians University Munich

Munich, Bavaria, 80799, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Uniklinik Köln

Cologne, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Technische Universität München

Munich, 80333, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Benedikt Westphalen

  LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 29, 2020
• Study Start: December 12, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

DE (6)