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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Patients are allocated to group A according to preoperative presence of detectable ctDNA. |
| |
| Group B | Patients are allocated to group B according to preoperative absence of detectable ctDNA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Biopsy | Other | 17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy. |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pancreatic mass, suspicious of pancreatic cancer and deemed resectable will be prospectively enrolled in this observational study.
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| Name | Affiliation | Role |
|---|---|---|
| Benedikt Westphalen | LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximilians University Munich | Munich | Bavaria | 80799 | Germany | ||
| Charité - Universitätsmedizin Berlin |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Berlin |
| Germany |
| Uniklinik Köln | Cologne | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Technische Universität München | Munich | 80333 | Germany |
| Universitätsklinikum Ulm | Ulm | Germany |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |