Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Pancreas Cancer Clinical Trial

— PROJECTION  

Official title:

Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246203
• Other study ID #: ML40429
• Status: Recruiting
• Start date: December 12, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: Benedikt Westphalen, MD
• Phone: 0049894400
• Email: cwestpha[@]med.lmu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Uniklinik Köln	Cologne
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Ludwig Maximilians University Munich	Munich	Bavaria
Germany	Technische Universität München	Munich
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.