Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Other: Liquid Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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. |