PROJECTION: Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- DFS [Follow up will be 36 months after surgery.]
Comparison of disease-free survival (DFS) of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients ≥ 18 years of age
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Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
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Patient deemed medically fit for adjuvant chemotherapy by the investigator
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Patient's legal capacity to consent to study participation
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Signed and dated informed consent to participate in the study
Exclusion Criteria:
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Non-resectable disease as determined by a local tumor board
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Metastatic pancreatic disease
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Previous neoadjuvant chemotherapy
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Previous neoadjuvant radiotherapy
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Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ludwig Maximilians University Munich | Munich | Bavaria | Germany | 80799 |
| 2 | Charité - Universitätsmedizin Berlin | Berlin | Germany | ||
| 3 | Uniklinik Köln | Cologne | Germany | ||
| 4 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | ||
| 5 | Technische Universität München | Munich | Germany | 80333 | |
| 6 | Universitätsklinikum Ulm | Ulm | Germany |
Sponsors and Collaborators
- Ludwig-Maximilians - University of Munich
- Hoffmann-La Roche
Investigators
- Principal Investigator: Benedikt Westphalen, LMU Munich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML40429